Trial Outcomes & Findings for Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa (NCT NCT04179175)

Last Updated: 2025-11-03

Results Overview

Loss of response was defined as: * at least a 50% increase in abscess and/or nodules (AN) count compared to the average AN count from the 3 previous visits or at Week 52, whichever is lower and the increase was at least of 3 AN. * at least a 30% increase in AN compared to the average AN count from the 3 previous visits or Week 52, whichever is lower, with an increase of at least 2 AN and a further increase in the AN count of at least 2 AN at a re-assessment visit within 2-4 weeks

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

703 participants

Primary outcome timeframe

Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies.

Results posted on

2025-11-03

Participant Flow

This study is conducted in 191 centers in 38 countries worldwide

Participant milestones

Participant milestones
Measure	AIN457 Q2WNR-Q2W HiSCR non-responders at Week 52 who were on secukinumab every 2 weeks (Q2W) in the core studies and stay on Q2W in the extension	AIN457 Q4WNR-Q2W HiSCR non-responders at Week 52 who were on secukinumab every 4 weeks (Q4W) in the core studies and are up-titrated to Q2W in the extension	AIN457 Q2WR-Q2W HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to Secukinumab Q2W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W	AIN457 Q2WR-PBO HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to placebo in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W	AIN457 Q4WR-Q4W HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to Secukinumab Q4W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR), patients could continue with open-label Secukinumab 300 mg Q2W. After Week 104, if no LOR, patients could continue with open-label Secukinumab 300 mg Q4W or be up titrated to Q2W at principal investigator discretion.	AIN457 Q4WR-PBO HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to placebo in the Randomized Withdrawal (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q4W or Q2W at principal investigator discretion
Overall Study STARTED	151	157	136	71	121	63
Overall Study Full Analysis Set of HiSCR Responders (FAS-R)	0	0	136	71	121	63
Overall Study Full Analysis Set of HiSCR Non-responders (FAS-NR)	151	156	0	0	0	0
Overall Study Safety Set (SAF)	151	156	137	70	121	63
Overall Study Completed Randomized Withdrawal Period - Responders Only	0	0	127	64	114	62
Overall Study COMPLETED	0	0	0	0	0	0
Overall Study NOT COMPLETED	151	157	136	71	121	63

Reasons for withdrawal

Reasons for withdrawal
Measure	AIN457 Q2WNR-Q2W HiSCR non-responders at Week 52 who were on secukinumab every 2 weeks (Q2W) in the core studies and stay on Q2W in the extension	AIN457 Q4WNR-Q2W HiSCR non-responders at Week 52 who were on secukinumab every 4 weeks (Q4W) in the core studies and are up-titrated to Q2W in the extension	AIN457 Q2WR-Q2W HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to Secukinumab Q2W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W	AIN457 Q2WR-PBO HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to placebo in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W	AIN457 Q4WR-Q4W HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to Secukinumab Q4W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR), patients could continue with open-label Secukinumab 300 mg Q2W. After Week 104, if no LOR, patients could continue with open-label Secukinumab 300 mg Q4W or be up titrated to Q2W at principal investigator discretion.	AIN457 Q4WR-PBO HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to placebo in the Randomized Withdrawal (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q4W or Q2W at principal investigator discretion
Overall Study Ongoing at the time of the data cut-off date	98	105	94	54	95	43
Overall Study Withdrawal by Subject	23	31	22	10	12	8
Overall Study Technical problems	0	0	0	0	1	1
Overall Study Adverse Event	6	6	5	3	3	4
Overall Study Lack of Efficacy	18	7	5	1	3	2
Overall Study Lost to Follow-up	4	5	5	3	2	2
Overall Study Physician Decision	1	1	2	0	2	3
Overall Study Pregnancy	1	2	3	0	3	0

Baseline Characteristics

Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AIN457 Q2WR-Q2W n=136 Participants HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to Secukinumab Q2W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W	AIN457 Q2WR-PBO n=71 Participants HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to placebo in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W	AIN457 Q4WR-Q4W n=121 Participants HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to Secukinumab Q4W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR), patients could continue with open-label Secukinumab 300 mg Q2W. After Week 104, if no LOR, patients could continue with open-label Secukinumab 300 mg Q4W or be up titrated to Q2W at principal investigator discretion.	AIN457 Q4WR-PBO n=63 Participants HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to placebo in the Randomized Withdrawal (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q4W or Q2W at principal investigator discretion	AIN457 Q2WNR-Q2W n=151 Participants HiSCR non-responders at Week 52 who were on secukinumab every 2 weeks (Q2W) in the core studies and stay on Q2W in the extension	AIN457 Q4WNR-Q2W n=157 Participants HiSCR non-responders at Week 52 who were on secukinumab every 4 weeks (Q4W) in the core studies and are up-titrated to Q2W in the extension	Total n=699 Participants Total of all reporting groups
Sex: Female, Male Male	63 Participants n=3 Participants	33 Participants n=15 Participants	57 Participants n=18 Participants	35 Participants n=4 Participants	60 Participants n=7 Participants	79 Participants n=8 Participants	327 Participants n=9 Participants
Age, Continuous	35.7 Years STANDARD_DEVIATION 11.26 • n=3 Participants	34.8 Years STANDARD_DEVIATION 10.55 • n=15 Participants	35.4 Years STANDARD_DEVIATION 12.59 • n=18 Participants	36.0 Years STANDARD_DEVIATION 11.32 • n=4 Participants	37.3 Years STANDARD_DEVIATION 11.00 • n=7 Participants	37.1 Years STANDARD_DEVIATION 11.13 • n=8 Participants	36.1 Years STANDARD_DEVIATION 11.31 • n=9 Participants
Sex: Female, Male Female	73 Participants n=3 Participants	38 Participants n=15 Participants	64 Participants n=18 Participants	28 Participants n=4 Participants	91 Participants n=7 Participants	78 Participants n=8 Participants	372 Participants n=9 Participants
Race/Ethnicity, Customized Asian	12 Participants n=3 Participants	11 Participants n=15 Participants	13 Participants n=18 Participants	6 Participants n=4 Participants	24 Participants n=7 Participants	28 Participants n=8 Participants	94 Participants n=9 Participants
Race/Ethnicity, Customized White	113 Participants n=3 Participants	51 Participants n=15 Participants	90 Participants n=18 Participants	48 Participants n=4 Participants	115 Participants n=7 Participants	111 Participants n=8 Participants	528 Participants n=9 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=3 Participants	6 Participants n=15 Participants	11 Participants n=18 Participants	7 Participants n=4 Participants	6 Participants n=7 Participants	14 Participants n=8 Participants	52 Participants n=9 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=4 Participants	1 Participants n=7 Participants	0 Participants n=8 Participants	1 Participants n=9 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=3 Participants	2 Participants n=15 Participants	5 Participants n=18 Participants	2 Participants n=4 Participants	3 Participants n=7 Participants	3 Participants n=8 Participants	17 Participants n=9 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=3 Participants	1 Participants n=15 Participants	2 Participants n=18 Participants	0 Participants n=4 Participants	2 Participants n=7 Participants	1 Participants n=8 Participants	7 Participants n=9 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies.

Population: Full Analysis Set of HiSCR responders (FAS-R)

Outcome measures

Outcome measures
Measure	AIN457 Q2WR-Q2W n=136 Participants HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to Secukinumab Q2W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W	AIN457 Q2WR-PBO n=71 Participants HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to placebo in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W	AIN457 Q4WR-Q4W n=121 Participants HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to Secukinumab Q4W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR), patients could continue with open-label Secukinumab 300 mg Q2W. After Week 104, if no LOR, patients could continue with open-label Secukinumab 300 mg Q4W or be up titrated to Q2W at principal investigator discretion.	AIN457 Q4WR-PBO n=63 Participants HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to placebo in the Randomized Withdrawal (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q4W or Q2W at principal investigator discretion	AIN457 Q2WNR-Q2W HiSCR non-responders at Week 52 who were on secukinumab every 2 weeks (Q2W) in the core studies and stay on Q2W in the extension	AIN457 Q4WNR-Q2W HiSCR non-responders at Week 52 who were on secukinumab every 4 weeks (Q4W) in the core studies and are up-titrated to Q2W in the extension
Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders	283 Days Interval 176.0 to N/A: Not estimable due to insufficient number of participants with events	239 Days Interval 120.0 to N/A: Not estimable due to insufficient number of participants with events	365 Days Interval 225.0 to N/A: Not estimable due to insufficient number of participants with events	171 Days Interval 113.0 to 337.0	—	—

PRIMARY outcome

Timeframe: Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies.

Population: Full Analysis Set of HiSCR responders (FAS-R) with an available value for the outcome measure.

The incidence rate of participants achieving Loss of Response (LOR) was based on the primary estimand. * Day 1 = Date of 1st dose intake in the extension study. * Subjects at risk = Subjects who did not have LOR and were not censored before or at the start of the specified time interval. * Incidence rate (%) = (number of subjects with LOR / number of subjects at risk) x 100.

Outcome measures

Outcome measures
Measure	AIN457 Q2WR-Q2W n=136 Participants HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to Secukinumab Q2W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W	AIN457 Q2WR-PBO n=71 Participants HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to placebo in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W	AIN457 Q4WR-Q4W n=121 Participants HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to Secukinumab Q4W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR), patients could continue with open-label Secukinumab 300 mg Q2W. After Week 104, if no LOR, patients could continue with open-label Secukinumab 300 mg Q4W or be up titrated to Q2W at principal investigator discretion.	AIN457 Q4WR-PBO n=63 Participants HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to placebo in the Randomized Withdrawal (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q4W or Q2W at principal investigator discretion	AIN457 Q2WNR-Q2W HiSCR non-responders at Week 52 who were on secukinumab every 2 weeks (Q2W) in the core studies and stay on Q2W in the extension	AIN457 Q4WNR-Q2W HiSCR non-responders at Week 52 who were on secukinumab every 4 weeks (Q4W) in the core studies and are up-titrated to Q2W in the extension
Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders 2 to 85 days	26.9 Percentage of participants	23.9 Percentage of participants	24.2 Percentage of participants	30.2 Percentage of participants	—	—
Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders 86 to 141 days	12.4 Percentage of participants	21.2 Percentage of participants	12.4 Percentage of participants	25.6 Percentage of participants	—	—
Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders 198 to 253 days	8.1 Percentage of participants	8.1 Percentage of participants	10.1 Percentage of participants	13.8 Percentage of participants	—	—
Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders 254 to 309 days	10.4 Percentage of participants	18.2 Percentage of participants	6.5 Percentage of participants	4.0 Percentage of participants	—	—
Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders 310 to 351 days	3.3 Percentage of participants	0.0 Percentage of participants	1.8 Percentage of participants	4.2 Percentage of participants	—	—
Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders 352 to 399 days	5.4 Percentage of participants	0.0 Percentage of participants	5.4 Percentage of participants	9.1 Percentage of participants	—	—
Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders Day 1	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	—	—
Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders 142 to 197 days	8.4 Percentage of participants	9.8 Percentage of participants	6.6 Percentage of participants	9.4 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Up to 216 weeks: from randomization at the extension study (Week 52) up to Week 268. Study day is defined with respect to the core studies.

To assess the long-term safety and tolerability of Secukinumab in subjects with moderate to severe hidradenitis suppurativa (HS)

Outcome measures

Outcome data not reported

Adverse Events

AIN457 Q2WR-PBO

Serious events: 4 serious events

Other events: 23 other events

Deaths: 0 deaths

AIN457 Q2WR-Q2W

Serious events: 2 serious events

Other events: 44 other events

Deaths: 0 deaths

AIN457 Q4WR-Q4W

Serious events: 5 serious events

Other events: 46 other events

Deaths: 0 deaths

AIN457 Q4WR-PBO

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

Any AIN457 Q4W

Serious events: 11 serious events

Other events: 71 other events

Deaths: 0 deaths

Any AIN457 Q2W

Serious events: 72 serious events

Other events: 379 other events

Deaths: 0 deaths

Any AIN457

Serious events: 80 serious events

Other events: 428 other events

Deaths: 0 deaths

AIN457 NR

Serious events: 37 serious events

Other events: 199 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AIN457 Q2WR-PBO n=70 participants at risk HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to placebo in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W	AIN457 Q2WR-Q2W n=137 participants at risk HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to Secukinumab Q2W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W	AIN457 Q4WR-Q4W n=121 participants at risk HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to Secukinumab Q4W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR), patients could continue with open-label Secukinumab 300 mg Q2W. After Week 104, if no LOR, patients could continue with open-label Secukinumab 300 mg Q4W or be up titrated to Q2W at principal investigator discretion.	AIN457 Q4WR-PBO n=63 participants at risk HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to placebo in the Randomized Withdrawal (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q4W or Q2W at principal investigator discretion	Any AIN457 Q4W n=180 participants at risk All subjects that have been exposed to secukinumab every 4 weeks (Q4W) in the extension study	Any AIN457 Q2W n=637 participants at risk All subjects that have been exposed to secukinumab every 2 weeks (Q2W) in the extension study, regardless of responder status at Week 52, including those who up-titrated	Any AIN457 n=687 participants at risk All subjects exposed to Secukinumab in the extension study regardless of the assigned drug regimen, and regardless of responder status	AIN457 NR n=307 participants at risk All subjects who are HiSCR non-responders
Cardiac disorders Acute coronary syndrome	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Cardiac disorders Acute myocardial infarction	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Cardiac disorders Atrial fibrillation	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Cardiac disorders Cardiac failure	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Cardiac disorders Cardiac failure congestive	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Cardiac disorders Coronary artery disease	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.83% 1/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Cardiac disorders Myocardial infarction	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Eye disorders Keratitis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Abdominal hernia	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Crohn's disease	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.47% 3/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.44% 3/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Inflammatory bowel disease	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Inguinal hernia	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Intussusception	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Strangulated umbilical hernia	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Swollen tongue	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Tongue coated	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 1/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders Chest pain	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders General physical health deterioration	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Hepatobiliary disorders Cholecystitis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.31% 2/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.29% 2/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Hepatobiliary disorders Cholelithiasis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.31% 2/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.29% 2/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Abscess	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Appendicitis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.83% 1/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.31% 2/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.44% 3/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.65% 2/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Breast abscess	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations COVID-19	1.4% 1/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.31% 2/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.29% 2/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations COVID-19 pneumonia	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Cellulitis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.47% 3/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.58% 4/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Chronic sinusitis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Dermatitis infected	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Diverticulitis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 1/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Gastroenteritis	1.4% 1/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Groin abscess	1.4% 1/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Influenza	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Meningitis viral	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Oesophageal candidiasis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 1/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Oral candidiasis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.31% 2/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.29% 2/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Pneumonia	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.31% 2/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.29% 2/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Pyelonephritis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.73% 1/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Sepsis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Sweat gland infection	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.47% 3/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.44% 3/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.65% 2/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Urinary tract infection	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.83% 1/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Skin scar contracture	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations C-reactive protein increased	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Obesity	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Fibrosis tendinous	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	1.4% 1/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Nervous system disorders Colloid brain cyst	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Nervous system disorders Ischaemic stroke	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Nervous system disorders Optic perineuritis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Nervous system disorders Syncope	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.83% 1/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.29% 2/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Psychiatric disorders Depression	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Psychiatric disorders Schizophrenia	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Renal and urinary disorders Hydronephrosis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Reproductive system and breast disorders Endometriosis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Reproductive system and breast disorders Labia enlarged	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 1/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Reproductive system and breast disorders Perineal induration	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 1/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Aorto-bronchial fistula	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Nasal turbinate hypertrophy	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Dermatitis psoriasiform	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.73% 1/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.83% 1/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 23/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.3% 23/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.6% 14/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 1/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Vascular disorders Peripheral artery stenosis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.16% 1/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.15% 1/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.

Other adverse events

Other adverse events
Measure	AIN457 Q2WR-PBO n=70 participants at risk HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to placebo in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W	AIN457 Q2WR-Q2W n=137 participants at risk HiSCR responders at Week 52 who were on Secukinumab every 2 weeks (Q2W) in the core studies and were randomized to Secukinumab Q2W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q2W	AIN457 Q4WR-Q4W n=121 participants at risk HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to Secukinumab Q4W in the Randomized Withdrawal Period (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR), patients could continue with open-label Secukinumab 300 mg Q2W. After Week 104, if no LOR, patients could continue with open-label Secukinumab 300 mg Q4W or be up titrated to Q2W at principal investigator discretion.	AIN457 Q4WR-PBO n=63 participants at risk HiSCR responders at Week 52 who were on Secukinumab every 4 weeks (Q4W) in the core studies and were randomized to placebo in the Randomized Withdrawal (Week 52 to Week 104 or loss of response) in the extension. After loss of response (LOR) or Week 104, patients could continue with open-label Secukinumab 300 mg Q4W or Q2W at principal investigator discretion	Any AIN457 Q4W n=180 participants at risk All subjects that have been exposed to secukinumab every 4 weeks (Q4W) in the extension study	Any AIN457 Q2W n=637 participants at risk All subjects that have been exposed to secukinumab every 2 weeks (Q2W) in the extension study, regardless of responder status at Week 52, including those who up-titrated	Any AIN457 n=687 participants at risk All subjects exposed to Secukinumab in the extension study regardless of the assigned drug regimen, and regardless of responder status	AIN457 NR n=307 participants at risk All subjects who are HiSCR non-responders
Blood and lymphatic system disorders Anaemia	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.3% 8/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.3% 9/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.6% 8/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	1.4% 1/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.83% 1/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 4/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.7% 17/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.1% 21/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.3% 10/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Toothache	2.9% 2/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.73% 1/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.7% 2/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.7% 3/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 15/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.6% 18/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.3% 7/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Gastrointestinal disorders Vomiting	1.4% 1/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.2% 2/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.1% 2/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.94% 6/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 8/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.3% 4/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders Fatigue	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.5% 2/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.7% 2/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.1% 2/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 14/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.3% 16/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.0% 6/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
General disorders Pyrexia	4.3% 3/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 3/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.83% 1/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 1/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.3% 6/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.3% 21/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.9% 27/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.3% 10/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Body tinea	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 3/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.94% 6/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.87% 6/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.33% 1/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Bronchitis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.5% 2/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.2% 2/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.4% 28/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.2% 29/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.6% 14/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations COVID-19	8.6% 6/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	8.0% 11/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	9.1% 11/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.1% 7/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.6% 19/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	20.1% 128/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	21.4% 147/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	18.9% 58/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Cellulitis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.7% 11/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 11/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.9% 9/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Ear infection	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.73% 1/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.0% 13/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.9% 13/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.3% 7/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Folliculitis	2.9% 2/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 3/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.2% 2/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 4/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.3% 8/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.7% 12/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.0% 6/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Gastroenteritis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 3/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.7% 2/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.7% 3/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.7% 11/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.0% 14/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.3% 4/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Influenza	1.4% 1/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.5% 2/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.7% 2/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 4/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.5% 22/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 25/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.3% 10/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Nasopharyngitis	2.9% 2/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 5/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.0% 6/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.2% 2/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.4% 8/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	8.6% 55/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	9.2% 63/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.4% 32/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Pharyngitis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 3/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 4/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 10/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.0% 14/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 5/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Sinusitis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.73% 1/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.83% 1/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 4/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.7% 17/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.1% 21/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.9% 9/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Subcutaneous abscess	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.83% 1/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.7% 3/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 14/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 17/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 11/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Sweat gland infection	1.4% 1/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.9% 4/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.83% 1/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 1/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 14/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.0% 14/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 5/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Tonsillitis	1.4% 1/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.5% 2/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 15/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.3% 16/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.0% 6/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Upper respiratory tract infection	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.73% 1/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 3/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 1/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.8% 5/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.4% 28/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.8% 33/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.6% 14/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Infections and infestations Urinary tract infection	2.9% 2/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 3/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.7% 2/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 1/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.7% 3/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.8% 18/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.1% 21/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.3% 7/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations Alanine aminotransferase increased	2.9% 2/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.1% 7/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.2% 8/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.98% 3/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations C-reactive protein increased	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.73% 1/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.1% 2/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.1% 20/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.2% 22/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.9% 15/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Investigations SARS-CoV-2 test positive	2.9% 2/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.3% 4/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.2% 2/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.8% 5/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.7% 17/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.2% 22/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.6% 11/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 3/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.94% 6/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.87% 6/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.65% 2/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.2% 2/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 3/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.3% 6/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.4% 15/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.9% 20/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.6% 8/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.5% 2/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.0% 19/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.9% 20/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.9% 9/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Nervous system disorders Headache	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 3/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.3% 4/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.0% 9/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	5.0% 32/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	6.0% 41/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.9% 15/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Psychiatric disorders Anxiety	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.3% 4/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 4/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 10/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.0% 14/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.3% 4/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 3/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.7% 3/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.1% 20/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.3% 23/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.6% 14/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 3/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.83% 1/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.7% 11/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.7% 12/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.0% 6/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	2.9% 2/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Acne	1.4% 1/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.7% 2/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.1% 2/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.1% 20/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.2% 22/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.6% 14/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.83% 1/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 10/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 11/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.3% 7/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Eczema	5.7% 4/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 3/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.5% 3/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 1/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 4/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.5% 22/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.8% 26/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.2% 13/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Hidradenitis	5.7% 4/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.4% 6/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.3% 4/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.8% 3/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.3% 6/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	11.0% 70/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	10.9% 75/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	14.7% 45/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.3% 4/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 4/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.8% 18/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.2% 22/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	4.2% 13/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.2% 2/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.73% 1/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	1.6% 1/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 14/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.2% 15/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.6% 8/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.
Vascular disorders Hypertension	0.00% 0/70 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/137 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/121 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.00% 0/63 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	0.56% 1/180 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.7% 17/637 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	2.6% 18/687 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.	3.3% 10/307 • From first dose of study treatment in the extension (Week 52) up to the cut-off date for the interim analysis (26-May-2023), approximately 3 years. Study day is defined with respect to the core studies. Any sign or symptom that occurred during the Randomized Withdrawal Period (for HiSCR responders only) and for the entire study period (from Week 52 up to the cut- off date for the Week 104 interim analysis) for both HiSCR responders and non- responders. The safety analysis were done on the safety population, which included all subjects who received at least one dose of study medication.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER