Trial Outcomes & Findings for A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis (NCT NCT05489224)

Last Updated: 2024-10-08

Results Overview

The DAS28(ESR) score was derived using the following formulae: DAS28 (ESR)=(0.56 ×√TJC28)+(0.28 × √SJC28)+(0.70 × ln\[ESR\])+(0.014 ×GH) Where: * TJC28 = number of tender joints (0-28): tender joint count (TJC) * SJC28 = number of swollen joints (0-28): swollen joint count (SJC) * ESR = ESR measurement (mm/hour) * GH = patient's global disease activity measured on VAS (mm: 0-100) DAS28 (ESR) values could be ranged from 0 to 10 while higher values mean a higher disease activity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

471 participants

Primary outcome timeframe

Week 24

Results posted on

2024-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	CT-P47/CT-P47 Maintenance Treatment Period I: Patients who were initially randomly assigned to CT-P47 in Treatment Period I (from Week 0 to Week 20). Treatment Period II: All patients who received CT-P47 in Treatment Period I and continued to receive CT-P47 in Treatment Period II (from Week 24 to Week 48).	RoActemra/RoActemra Maintenance Treatment Period I: Patients who were initially randomly assigned to RoActemra in Treatment Period I (from Week 0 to Week 20). Treatment Period II: Patients who received RoActemra in Treatment Period I and re-randomized to continue RoActemra in Treatment Period II (from Week 24 to Week 48).	Switched to CT-P47 Treatment Period I: Not applicable Treatment Period II: Patients who received RoActemra in Treatment Period I and re-randomized to receive CT-P47 in Treatment Period II (from Week 24 to Week 48).
Treatment Period I STARTED	234	237	0
Treatment Period I COMPLETED	225	219	0
Treatment Period I NOT COMPLETED	9	18	0
Treatment Period II up to Week 32 STARTED	225	109	110
Treatment Period II up to Week 32 COMPLETED	0	0	0
Treatment Period II up to Week 32 NOT COMPLETED	225	109	110

Reasons for withdrawal

Reasons for withdrawal
Measure	CT-P47/CT-P47 Maintenance Treatment Period I: Patients who were initially randomly assigned to CT-P47 in Treatment Period I (from Week 0 to Week 20). Treatment Period II: All patients who received CT-P47 in Treatment Period I and continued to receive CT-P47 in Treatment Period II (from Week 24 to Week 48).	RoActemra/RoActemra Maintenance Treatment Period I: Patients who were initially randomly assigned to RoActemra in Treatment Period I (from Week 0 to Week 20). Treatment Period II: Patients who received RoActemra in Treatment Period I and re-randomized to continue RoActemra in Treatment Period II (from Week 24 to Week 48).	Switched to CT-P47 Treatment Period I: Not applicable Treatment Period II: Patients who received RoActemra in Treatment Period I and re-randomized to receive CT-P47 in Treatment Period II (from Week 24 to Week 48).
Treatment Period I Adverse Event	3	11	0
Treatment Period I Withdrawal by Subject	6	5	0
Treatment Period I Lost to Follow-up	0	1	0
Treatment Period I Physician Decision	0	1	0
Treatment Period II up to Week 32 Ongoing	222	107	107
Treatment Period II up to Week 32 Adverse Event	3	0	1
Treatment Period II up to Week 32 Withdrawal by Subject	0	2	2

Baseline Characteristics

A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CT-P47 n=234 Participants Patients who were initially randomly assigned to CT-P47 in Treatment Period I.	RoActemra n=237 Participants Patients who were initially randomly assigned to RoActemra in Treatment Period I.	Total n=471 Participants Total of all reporting groups
Age, Continuous	55.1 years STANDARD_DEVIATION 10.98 • n=5 Participants	54.4 years STANDARD_DEVIATION 11.61 • n=7 Participants	54.8 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	181 Participants n=5 Participants	180 Participants n=7 Participants	361 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	57 Participants n=7 Participants	110 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	234 Participants n=5 Participants	237 Participants n=7 Participants	471 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Non-Hispanic or Non-Latino	228 Participants n=5 Participants	233 Participants n=7 Participants	461 Participants n=5 Participants
Body Weight on Day 1 <100 kg	208 Participants n=5 Participants	210 Participants n=7 Participants	418 Participants n=5 Participants
Body Weight on Day 1 ≥100 kg	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants
DAS28 (ESR) score at Screening DAS28 (ESR) >5.1	229 Participants n=5 Participants	230 Participants n=7 Participants	459 Participants n=5 Participants
DAS28 (ESR) score at Screening DAS28 (ESR) ≤5.1	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Prior biologic use approved for RA treatment Yes	58 Participants n=5 Participants	62 Participants n=7 Participants	120 Participants n=5 Participants
Prior biologic use approved for RA treatment No	176 Participants n=5 Participants	175 Participants n=7 Participants	351 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: ITT set

Outcome measures

Outcome measures
Measure	CT-P47 n=234 Participants Patients who were initially randomly assigned to CT-P47 in Treatment Period I.	RoActemra n=237 Participants Patients who were initially randomly assigned to RoActemra in Treatment Period I.	Switched to CT-P47 Patients who were initially randomly assigned to RoActemra at Day 1 (Week 0) and re-randomized (1:1 ratio) at Week 24 to undergo transition to CT-P47 in Treatment Period II.
Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 24	-3.77 units on a scale Standard Error 0.120	-3.67 units on a scale Standard Error 0.118	—

SECONDARY outcome

Timeframe: Week 32

Population: ITT-Treatment Period II Subset

Outcome measures

Outcome measures
Measure	CT-P47 n=225 Participants Patients who were initially randomly assigned to CT-P47 in Treatment Period I.	RoActemra n=109 Participants Patients who were initially randomly assigned to RoActemra in Treatment Period I.	Switched to CT-P47 n=110 Participants Patients who were initially randomly assigned to RoActemra at Day 1 (Week 0) and re-randomized (1:1 ratio) at Week 24 to undergo transition to CT-P47 in Treatment Period II.
Mean Change From Baseline in DAS28 (ESR) at Week 32	-3.921 units on a scale Standard Deviation 1.2548	-3.994 units on a scale Standard Deviation 1.1753	-4.218 units on a scale Standard Deviation 1.1380

SECONDARY outcome

Timeframe: Week 24

Population: ITT set

ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.

Outcome measures

Outcome measures
Measure	CT-P47 n=234 Participants Patients who were initially randomly assigned to CT-P47 in Treatment Period I.	RoActemra n=237 Participants Patients who were initially randomly assigned to RoActemra in Treatment Period I.	Switched to CT-P47 Patients who were initially randomly assigned to RoActemra at Day 1 (Week 0) and re-randomized (1:1 ratio) at Week 24 to undergo transition to CT-P47 in Treatment Period II.
ACR20, ACR50, and ACR70 Response Rate at Week 24 ACR20	199 Participants	189 Participants	—
ACR20, ACR50, and ACR70 Response Rate at Week 24 ACR50	142 Participants	146 Participants	—
ACR20, ACR50, and ACR70 Response Rate at Week 24 ACR70	100 Participants	99 Participants	—

SECONDARY outcome

Timeframe: Week 32

Population: ITT-Treatment Period II Subset

Outcome measures

Outcome measures
Measure	CT-P47 n=225 Participants Patients who were initially randomly assigned to CT-P47 in Treatment Period I.	RoActemra n=109 Participants Patients who were initially randomly assigned to RoActemra in Treatment Period I.	Switched to CT-P47 n=110 Participants Patients who were initially randomly assigned to RoActemra at Day 1 (Week 0) and re-randomized (1:1 ratio) at Week 24 to undergo transition to CT-P47 in Treatment Period II.
ACR20, ACR50, and ACR70 Response Rate at Week 32 ACR20	199 Participants	96 Participants	98 Participants
ACR20, ACR50, and ACR70 Response Rate at Week 32 ACR50	148 Participants	79 Participants	77 Participants
ACR20, ACR50, and ACR70 Response Rate at Week 32 ACR70	91 Participants	47 Participants	61 Participants

Adverse Events

Treatment Period I: CT-P47

Serious events: 10 serious events

Other events: 140 other events

Deaths: 0 deaths

Treatment Period I: RoActemra

Serious events: 9 serious events

Other events: 143 other events

Deaths: 0 deaths

Treatment Period II: CT-P47 Maintenance

Serious events: 4 serious events

Other events: 54 other events

Deaths: 1 deaths

Treatment Period II: RoActemra Maintenance

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Treatment Period II: Switched to CT-P47

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Period I: CT-P47 n=234 participants at risk Patients who were initially randomly assigned to CT-P47 in Treatment Period I	Treatment Period I: RoActemra n=237 participants at risk Patients who were initially randomly assigned to RoActemra in Treatment Period I	Treatment Period II: CT-P47 Maintenance n=225 participants at risk Patients who received CT-P47 during Treatment Period I and continued to receive CT-P47 in Treatment Period II	Treatment Period II: RoActemra Maintenance n=109 participants at risk Patients who were initially randomly assigned to RoActemra at Day 1 (Week 0) and re-randomized (1:1 ratio) at Week 24 to continue to receive RoActemra in Treatment Period II	Treatment Period II: Switched to CT-P47 n=110 participants at risk Patients who were initially randomly assigned to RoActemra at Day 1 (Week 0) and re-randomized (1:1 ratio) at Week 24 to undergo transition to CT-P47 in Treatment Period II
Cardiac disorders Acute myocardial infarction	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.42% 1/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Cardiac disorders Coronary artery disease	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.42% 1/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Cardiac disorders Myocardial ischaemia	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.84% 2/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Gastrointestinal disorders Inguinal hernia	0.43% 1/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Infections and infestations COVID-19 pneumonia	0.43% 1/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Infections and infestations Erysipelas	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.42% 1/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Infections and infestations Lyme disease	0.43% 1/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Infections and infestations Pyelonephritis	0.43% 1/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Infections and infestations Urosepsis	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.42% 1/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Infections and infestations Arthritis bacterial	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.92% 1/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Infections and infestations Peritonitis	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.44% 1/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Infections and infestations Pneumonia	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.44% 1/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
General disorders Peripheral swelling	0.43% 1/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.42% 1/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Musculoskeletal and connective tissue disorders Bone loss	0.43% 1/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.42% 1/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Nervous system disorders Monoparesis	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.42% 1/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Psychiatric disorders Schizophrenia	0.43% 1/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Investigations Interferon gamma release assay positive	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.44% 1/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.92% 1/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Nervous system disorders Syncope	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.44% 1/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Reproductive system and breast disorders Cervical cyst	0.43% 1/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.42% 1/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.91% 1/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Vascular disorders Extremity necrosis	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.42% 1/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Vascular disorders Venous thrombosis limb	0.43% 1/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.91% 1/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.44% 1/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
General disorders Chest pain	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.92% 1/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.43% 1/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Cardiac disorders Coronary artery stenosis	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.42% 1/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.

Other adverse events

Other adverse events
Measure	Treatment Period I: CT-P47 n=234 participants at risk Patients who were initially randomly assigned to CT-P47 in Treatment Period I	Treatment Period I: RoActemra n=237 participants at risk Patients who were initially randomly assigned to RoActemra in Treatment Period I	Treatment Period II: CT-P47 Maintenance n=225 participants at risk Patients who received CT-P47 during Treatment Period I and continued to receive CT-P47 in Treatment Period II	Treatment Period II: RoActemra Maintenance n=109 participants at risk Patients who were initially randomly assigned to RoActemra at Day 1 (Week 0) and re-randomized (1:1 ratio) at Week 24 to continue to receive RoActemra in Treatment Period II	Treatment Period II: Switched to CT-P47 n=110 participants at risk Patients who were initially randomly assigned to RoActemra at Day 1 (Week 0) and re-randomized (1:1 ratio) at Week 24 to undergo transition to CT-P47 in Treatment Period II
Blood and lymphatic system disorders Leukopenia	8.5% 20/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	10.5% 25/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	4.9% 11/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	6.4% 7/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Blood and lymphatic system disorders Lymphopenia	3.8% 9/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	5.5% 13/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Blood and lymphatic system disorders Neutropenia	8.1% 19/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	9.7% 23/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	2.2% 5/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	1.8% 2/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	4.5% 5/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Blood and lymphatic system disorders Thrombocytopenia	3.8% 9/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	3.4% 8/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Immune system disorders Hypersensitivity	1.3% 3/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	3.4% 8/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Infections and infestations Nasopharyngitis	7.7% 18/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	8.0% 19/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Infections and infestations Pharyngitis	3.8% 9/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	1.7% 4/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Infections and infestations Upper respiratory tract infection	21.4% 50/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	16.9% 40/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	4.4% 10/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	6.4% 7/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	3.6% 4/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Infections and infestations Latent tuberculosis	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	5.3% 12/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	1.8% 2/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	2.7% 3/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Investigations Alanine aminotransferase increased	15.8% 37/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	20.3% 48/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	7.6% 17/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	6.4% 7/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	4.5% 5/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Investigations Aspartate aminotransferase increased	5.1% 12/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	7.2% 17/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	4.4% 10/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	4.6% 5/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	4.5% 5/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Investigations Transaminases increased	2.6% 6/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	4.6% 11/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Investigations Blood creatine phosphokinase MB increased	0.00% 0/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	2.2% 5/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	4.6% 5/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	1.8% 2/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Metabolism and nutrition disorders Hypercholesterolaemia	6.8% 16/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	8.0% 19/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Metabolism and nutrition disorders Hyperlipidaemia	3.4% 8/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	2.1% 5/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Nervous system disorders Headache	3.0% 7/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	3.8% 9/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Vascular disorders Hypertension	3.8% 9/234 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	5.1% 12/237 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/225 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/109 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.	0.00% 0/110 • Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included. Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included. Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.

Additional Information

Head of Clinical Planning Department 3

CELLTRION, Inc.

Phone: +82-32-850-4167

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER