Trial Outcomes & Findings for Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis (NCT NCT01639339)

NCT ID: NCT01639339

Last Updated: 2021-03-19

Results Overview

PERR is defined as urinary protein creatinine ratio \<=0.7, estimated glomerular filtration rate (eGRF) was not more than 20 percent (%) below the pre-flare value or \>=60 milliliters per minute per 1.73 square meter (mL/min/1.73m\^2) and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates treatment group, induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline urine protein-creatinine ratio (uPCR), and Baseline eGFR. Modified Intent-to-treat (mITT) Population consisted of all randomized participants who received at least one dose of study treatment and were not excluded due to Good Clinical Practice (GCP) non-compliance. Percentage of participants with PERR at Week 104 has been presented.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 448 participants
• Primary outcome timeframe: Week 104
• Results posted on: 2021-03-19

Participant Flow

This study evaluated safety and efficacy of intravenous (IV) belimumab 10 mg/kg plus standard of care (SoC) compared to placebo plus SoC in adult participants with active lupus nephritis. This was a Phase 3, multi-center, multi-national study consisting of a randomized, double-blind, placebo-controlled period and an open-label extension period. The study was conducted in 21 countries.

A total of 797 participants were screened of which 349 participants failed screening and 448 participants were randomized in double-blind period. In open-label period, a total of 257 participants were enrolled of which 2 participants did not receive open-label study treatment and 255 participants received open-label belimumab.

Participant milestones

Measure	Placebo to Belimumab 10 mg/kg Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	Belimumab 10 mg/kg to Belimumab 10 Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
Double-blind Period (Up to Week 104) STARTED	224	224
Double-blind Period (Up to Week 104) COMPLETED	170	186
Double-blind Period (Up to Week 104) NOT COMPLETED	54	38
Open-label Period (Up to Week 28) STARTED	123	132
Open-label Period (Up to Week 28) COMPLETED	122	124
Open-label Period (Up to Week 28) NOT COMPLETED	1	8

Reasons for withdrawal

Measure	Placebo to Belimumab 10 mg/kg Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	Belimumab 10 mg/kg to Belimumab 10 Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
Double-blind Period (Up to Week 104) Withdrawal by Subject	26	19
Double-blind Period (Up to Week 104) Physician Decision	11	5
Double-blind Period (Up to Week 104) Lost to Follow-up	5	4
Double-blind Period (Up to Week 104) Protocol Violation	0	2
Double-blind Period (Up to Week 104) Lack of Efficacy	2	1
Double-blind Period (Up to Week 104) Adverse Event	10	7
Open-label Period (Up to Week 28) Withdrawal by Subject	0	2
Open-label Period (Up to Week 28) Lost to Follow-up	0	1
Open-label Period (Up to Week 28) Protocol Violation	0	1
Open-label Period (Up to Week 28) Adverse Event	1	4

Baseline Characteristics

Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis

Baseline characteristics by cohort

Measure	Placebo to Belimumab 10 mg/kg n=224 Participants Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	Belimumab 10 mg/kg to Belimumab 10 n=224 Participants Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	Total n=448 Participants Total of all reporting groups
Age, Continuous	33.0 Years STANDARD_DEVIATION 10.64 • n=5 Participants	33.7 Years STANDARD_DEVIATION 10.73 • n=7 Participants	33.4 Years STANDARD_DEVIATION 10.68 • n=5 Participants
Sex: Female, Male Female	196 Participants n=5 Participants	198 Participants n=7 Participants	394 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized American Indian (AI) or Alaska Native (AN)	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Central/South Asian Heritage (H)	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Japanese/East Asian/Southeast Asian H	107 Participants n=5 Participants	112 Participants n=7 Participants	219 Participants n=5 Participants
Race/Ethnicity, Customized Mixed Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American (AA)	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian/European H	71 Participants n=5 Participants	72 Participants n=7 Participants	143 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian/Arabic/North African H	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Multiple-AA/African H and AI or AN and White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Multiple-Asian and White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 104

Population: mITT Population.

PERR is defined as urinary protein creatinine ratio <=0.7, estimated glomerular filtration rate (eGRF) was not more than 20 percent (%) below the pre-flare value or >=60 milliliters per minute per 1.73 square meter (mL/min/1.73m^2) and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates treatment group, induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline urine protein-creatinine ratio (uPCR), and Baseline eGFR. Modified Intent-to-treat (mITT) Population consisted of all randomized participants who received at least one dose of study treatment and were not excluded due to Good Clinical Practice (GCP) non-compliance. Percentage of participants with PERR at Week 104 has been presented.

Outcome measures

Measure	Belimumab 10 mg/kg to Belimumab 10 mg/kg n=223 Participants Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	Placebo n=223 Participants Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race.
Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104	43.0 Percentage of participants	32.3 Percentage of participants

PRIMARY outcome

Timeframe: From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)

Population: Safety Open-Label Population comprised of all participants who received at least one dose of open-label treatment.

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported.

Outcome measures

Measure	Belimumab 10 mg/kg to Belimumab 10 mg/kg n=132 Participants Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	Placebo n=123 Participants Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race.
Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs) Any AE	92 Participants	76 Participants
Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs) Any SAE	10 Participants	5 Participants

PRIMARY outcome

Timeframe: From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)

Population: Safety Open-Label Population.

An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections [OI], Herpes Zoster [HZ], tuberculosis [TB], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths.

Outcome measures

Measure	Belimumab 10 mg/kg to Belimumab 10 mg/kg n=132 Participants Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	Placebo n=123 Participants Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race.
Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) Malignancies excluding NMSC	0 Participants	0 Participants
Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) Malignancies including NMSC	0 Participants	0 Participants
Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) PISR	5 Participants	4 Participants
Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) All infections of special interest	6 Participants	2 Participants
Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) Depression/suicide/self-injury	4 Participants	2 Participants
Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) Deaths	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 104

Population: mITT Population.

CRR is defined as urinary protein creatinine ratio <0.5, eGRF was not more than 10% below the pre-flare value or >=90 mL/min/1.73m^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline uPCR and Baseline eGFR. Percentage of participants with CRR at Week 104 has been presented.

Outcome measures

Measure	Belimumab 10 mg/kg to Belimumab 10 mg/kg n=223 Participants Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	Placebo n=223 Participants Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race.
Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104	30.0 Percentage of participants	19.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: mITT Population.

PERR is defined as urinary protein creatinine ratio <=0.7, eGRF was not more than 20% below the pre-flare value or >=60 mL/min/1.73m^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), uPCR, and Baseline eGFR. Percentage of participants with PERR at Week 52 has been presented.

Outcome measures

Measure	Belimumab 10 mg/kg to Belimumab 10 mg/kg n=223 Participants Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	Placebo n=223 Participants Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race.
Double-blind Period: Percentage of Participants With PERR at Week 52	46.6 Percentage of participants	35.4 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 104

Population: mITT Population.

Events are defined as the first event experienced among the following: death, progression to end stage renal disease, doubling of serum creatinine from Baseline, renal worsening or renal-related treatment failure. Participants who discontinued randomized treatment, withdrew from the study, were lost to follow-up, or had a non renal-related treatment failure were censored. Participants who completed the 104-week treatment period were censored at the Week 104 visit. Time to event is defined as event date minus treatment start date plus one. Analysis was performed using Cox proportional hazards model for the comparison between Belimumab and Placebo adjusting for induction regimen, race, Baseline uPCR and Baseline eGFR. Number of participants with time to death or renal related event up to Week 104 has been presented.

Outcome measures

Measure	Belimumab 10 mg/kg to Belimumab 10 mg/kg n=223 Participants Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	Placebo n=223 Participants Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race.
Double-blind Period: Number of Participants With Time to Death or Renal Related Event	35 Participants	63 Participants

SECONDARY outcome

Timeframe: Week 104

Population: mITT Population.

ORR is defined with respect to reproducible responses that included CRR, partial RR (PRR) and non responder. CRR is reported when uPCR was <0.5, eGFR was not more than 10% below pre-flare GFR or within normal range and not a treatment failure. PRR is >=50% decrease from Baseline in uPCR and one of the following: value <1 if Baseline <=3, or value <3 if the Baseline was >3, eGFR not more than 10% below Baseline GFR or within normal range and not a treatment failure and not a CRR. Non responder is reported when neither CRR nor PRR criteria was met. Percentage of participants reporting CRR, PRR and non responders at Week 104 has been presented.

Outcome measures

Measure	Belimumab 10 mg/kg to Belimumab 10 mg/kg n=223 Participants Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	Placebo n=223 Participants Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race.
Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104 Non responder	52.5 Percentage of participants	63.2 Percentage of participants
Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104 CRR	30.0 Percentage of participants	19.7 Percentage of participants
Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104 PRR	17.5 Percentage of participants	17.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 104

Population: Safety Population comprised of all randomized participants who received at least one dose of study treatment.

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with on-treatment AEs and SAEs has been reported.

Outcome measures

Measure	Belimumab 10 mg/kg to Belimumab 10 mg/kg n=224 Participants Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	Placebo n=224 Participants Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race.
Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs Any AE	214 Participants	211 Participants
Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs Any SAE	58 Participants	67 Participants

SECONDARY outcome

Timeframe: Up to Week 104

Population: Safety Population.

An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections [OI], Herpes Zoster [HZ], tuberculosis [TB], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths. On-treatment data is displayed.

Outcome measures

Measure	Belimumab 10 mg/kg to Belimumab 10 mg/kg n=224 Participants Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	Placebo n=224 Participants Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race.
Double-blind Period: Number of Participants Reporting AESI Malignancies including NMSC	3 Participants	0 Participants
Double-blind Period: Number of Participants Reporting AESI Malignancies excluding NMSC	2 Participants	0 Participants
Double-blind Period: Number of Participants Reporting AESI PISR	26 Participants	29 Participants
Double-blind Period: Number of Participants Reporting AESI All infections of special interest	30 Participants	34 Participants
Double-blind Period: Number of Participants Reporting AESI Depression/suicide/self-injury	11 Participants	16 Participants
Double-blind Period: Number of Participants Reporting AESI Deaths	4 Participants	3 Participants

Adverse Events

Placebo

Serious events: 78 serious events

Other events: 191 other events

Deaths: 5 deaths

Belimumab 10 mg/kg

Serious events: 65 serious events

Other events: 186 other events

Deaths: 6 deaths

Placebo to Belimumab 10 mg/kg

Serious events: 5 serious events

Other events: 34 other events

Deaths: 1 deaths

Belimumab 10 mg/kg to Belimumab 10 mg/kg

Serious events: 10 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=224 participants at risk Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race.	Belimumab 10 mg/kg n=224 participants at risk Participants were randomized to receive Belimumab 10 milligrams per kilogram (mg/kg) IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.	Placebo to Belimumab 10 mg/kg n=123 participants at risk Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	Belimumab 10 mg/kg to Belimumab 10 mg/kg n=132 participants at risk Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
Infections and infestations Pneumonia	4.5% 10/224 • Number of events 11 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	4.5% 10/224 • Number of events 11 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	1.6% 2/123 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.76% 1/132 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Herpes zoster	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	1.8% 4/224 • Number of events 4 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.76% 1/132 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Lung infection	1.8% 4/224 • Number of events 4 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Urinary tract infection	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	1.8% 4/224 • Number of events 4 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Gastroenteritis	2.2% 5/224 • Number of events 5 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Cellulitis	1.3% 3/224 • Number of events 3 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.76% 1/132 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Sepsis	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Subcutaneous abscess	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.89% 2/224 • Number of events 3 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Bronchitis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Cytomegalovirus colitis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Endocarditis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Influenza	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Pulmonary tuberculosis	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Pyelonephritis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.76% 1/132 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Upper respiratory tract infection	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Abscess limb	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Acute sinusitis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.76% 1/132 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Appendicitis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Arthritis bacterial	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Bacteraemia	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Bone abscess	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Clostridium difficile colitis	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.76% 1/132 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Cytomegalovirus infection	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Diverticulitis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Enteritis infectious	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Enterocolitis bacterial	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Enterocolitis viral	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Escherichia urinary tract infection	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Furuncle	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Herpes oesophagitis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Large intestine infection	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Periorbital cellulitis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Peritonitis bacterial	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Pneumonia bacterial	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Pneumonia cytomegaloviral	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Pneumonia streptococcal	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Proteus infection	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Pulmonary nocardiosis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Respiratory syncytial virus bronchitis	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Rhodococcus infection	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Septic shock	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Sinusitis	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Staphylococcal abscess	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Staphylococcal infection	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Tuberculosis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Urosepsis	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Varicella	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Varicella zoster viral infection	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Viral infection	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Wound infection	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Renal and urinary disorders Lupus nephritis	3.6% 8/224 • Number of events 10 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Renal and urinary disorders Acute kidney injury	2.2% 5/224 • Number of events 5 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Renal and urinary disorders End stage renal disease	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.89% 2/224 • Number of events 4 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Renal and urinary disorders Renal impairment	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Renal and urinary disorders Azotaemia	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Renal and urinary disorders Nephrolithiasis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Renal and urinary disorders Renal failure	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.81% 1/123 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	1.8% 4/224 • Number of events 4 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Arthralgia	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Back pain	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Flank pain	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Oligoarthritis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Vomiting	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.81% 1/123 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Diarrhoea	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	1.3% 3/224 • Number of events 3 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Gastritis	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Nausea	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.81% 1/123 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Pancreatitis	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Abdominal pain	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Chronic gastritis	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Enteritis	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Epiploic appendagitis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Gastrointestinal inflammation	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Haemorrhoids	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Large intestine perforation	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Vasculitis gastrointestinal	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Blood and lymphatic system disorders Anaemia	2.7% 6/224 • Number of events 6 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	1.3% 3/224 • Number of events 3 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Blood and lymphatic system disorders Leukopenia	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Blood and lymphatic system disorders Bone marrow toxicity	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Blood and lymphatic system disorders Hypoglobulinaemia	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Blood and lymphatic system disorders Lymphadenopathy	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
General disorders Pyrexia	1.3% 3/224 • Number of events 3 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
General disorders Non-cardiac chest pain	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
General disorders Asthenia	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
General disorders Fatigue	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
General disorders Generalised oedema	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
General disorders Mucosal inflammation	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
General disorders Pain	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
General disorders Serositis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
General disorders Systemic inflammatory response syndrome	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Respiratory, thoracic and mediastinal disorders Organizing pneumonia	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Nervous system disorders Cerebral infarction	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Nervous system disorders Cerebrovascular accident	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Nervous system disorders Central nervous system lupus	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Nervous system disorders Encephalopathy	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Nervous system disorders Epilepsy	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Nervous system disorders Generalized tonic-clonic seizure	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Nervous system disorders Haemorrhage intracranial	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Nervous system disorders Headache	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.81% 1/123 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Nervous system disorders Hypertensive encephalopathy	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Nervous system disorders Metabolic encephalopathy	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Nervous system disorders Polyneuropathy	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Nervous system disorders Seizure	0.45% 1/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Vascular disorders Hypertension	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Vascular disorders Hypotension	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Vascular disorders Deep vein thrombosis	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Vascular disorders Hypertensive emergency	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Vascular disorders Shock haemorrhagic	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Vascular disorders Thrombosis	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Cardiac disorders Pericardial effusion	1.3% 3/224 • Number of events 4 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Cardiac disorders Aortic valve incompetence	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Cardiac disorders Cardiac failure acute	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Cardiac disorders Cardiac failure congestive	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Cardiac disorders Pericarditis	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Cardiac disorders Pericarditis uraemic	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Cardiac disorders Supraventricular tachycardia	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.89% 2/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Injury, poisoning and procedural complications Brain herniation	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Injury, poisoning and procedural complications Contusion	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Injury, poisoning and procedural complications Head injury	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Injury, poisoning and procedural complications Joint injury	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Injury, poisoning and procedural complications Spinal compression fracture	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Investigations Blood creatinine increased	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Investigations Blood immunoglobulin G decreased	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Investigations Foetal biophysical profile score equivocal	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Investigations Hepatic enzyme increased	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Investigations Weight decreased	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Metabolism and nutrition disorders Hyperkalaemia	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Metabolism and nutrition disorders Hypophagia	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Metabolism and nutrition disorders Metabolic acidosis	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Pregnancy, puerperium and perinatal conditions Foetal death	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Pregnancy, puerperium and perinatal conditions Prolonged labour	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Skin and subcutaneous tissue disorders Angioedema	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Skin and subcutaneous tissue disorders Erythema annulare	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Skin and subcutaneous tissue disorders Systemic lupus erythematosus rash	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Immune system disorders Hypersensitivity	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Immune system disorders Immunosuppression	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Psychiatric disorders Mental status changes	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Psychiatric disorders Suicide attempt	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.76% 1/132 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Endocrine disorders Hyperparathyroidism	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Complicated appendicitis	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.81% 1/123 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Disseminated tuberculosis	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.76% 1/132 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Genital infection	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.81% 1/123 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Otitis media	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.76% 1/132 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Pyelonephritis acute	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.81% 1/123 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.81% 1/123 • Number of events 2 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.76% 1/132 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Cardiac disorders Acute myocardial infarction	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.76% 1/132 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Cyclic vomiting syndrome	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.81% 1/123 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.81% 1/123 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
General disorders Multiple organ dysfunction syndrome	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.81% 1/123 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Pregnancy, puerperium and perinatal conditions Unintended pregnancy	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.76% 1/132 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Reproductive system and breast disorders Cervical dysplasia	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Reproductive system and breast disorders Endometriosis	0.00% 0/224 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.45% 1/224 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.

Other adverse events

Measure	Placebo n=224 participants at risk Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race.	Belimumab 10 mg/kg n=224 participants at risk Participants were randomized to receive Belimumab 10 milligrams per kilogram (mg/kg) IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.	Placebo to Belimumab 10 mg/kg n=123 participants at risk Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	Belimumab 10 mg/kg to Belimumab 10 mg/kg n=132 participants at risk Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
Infections and infestations Upper respiratory tract infection	33.0% 74/224 • Number of events 134 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	36.2% 81/224 • Number of events 159 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	11.4% 14/123 • Number of events 18 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	17.4% 23/132 • Number of events 24 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Urinary tract infection	16.5% 37/224 • Number of events 72 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	19.2% 43/224 • Number of events 73 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	8.1% 10/123 • Number of events 12 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	9.1% 12/132 • Number of events 14 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Nasopharyngitis	13.8% 31/224 • Number of events 50 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	15.6% 35/224 • Number of events 60 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	6.5% 8/123 • Number of events 9 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	2.3% 3/132 • Number of events 3 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Gastroenteritis	10.3% 23/224 • Number of events 28 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	9.4% 21/224 • Number of events 24 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Bronchitis	8.5% 19/224 • Number of events 26 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	8.0% 18/224 • Number of events 24 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Herpes zoster	8.5% 19/224 • Number of events 20 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	7.6% 17/224 • Number of events 17 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Infections and infestations Conjunctivitis	2.2% 5/224 • Number of events 5 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	5.8% 13/224 • Number of events 13 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Diarrhoea	21.4% 48/224 • Number of events 56 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	20.1% 45/224 • Number of events 59 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Nausea	10.7% 24/224 • Number of events 33 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	9.4% 21/224 • Number of events 28 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Vomiting	7.1% 16/224 • Number of events 21 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	7.1% 16/224 • Number of events 25 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Abdominal pain	5.8% 13/224 • Number of events 13 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	5.4% 12/224 • Number of events 15 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Dyspepsia	6.7% 15/224 • Number of events 18 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	4.0% 9/224 • Number of events 10 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Gastrointestinal disorders Abdominal pain upper	2.7% 6/224 • Number of events 7 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	7.1% 16/224 • Number of events 16 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 32/224 • Number of events 52 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	11.6% 26/224 • Number of events 44 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	4.1% 5/123 • Number of events 5 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	5.3% 7/132 • Number of events 8 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Back pain	7.6% 17/224 • Number of events 17 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	7.6% 17/224 • Number of events 24 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Muscle spasms	6.7% 15/224 • Number of events 18 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	8.0% 18/224 • Number of events 25 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Musculoskeletal and connective tissue disorders Pain in extremity	3.6% 8/224 • Number of events 9 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	5.4% 12/224 • Number of events 14 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Nervous system disorders Headache	15.6% 35/224 • Number of events 57 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	15.2% 34/224 • Number of events 51 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Nervous system disorders Dizziness	8.5% 19/224 • Number of events 21 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	5.8% 13/224 • Number of events 18 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
General disorders Oedema peripheral	5.8% 13/224 • Number of events 17 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	7.1% 16/224 • Number of events 23 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
General disorders Pyrexia	7.6% 17/224 • Number of events 20 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	4.9% 11/224 • Number of events 14 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
General disorders Fatigue	6.2% 14/224 • Number of events 15 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	5.4% 12/224 • Number of events 12 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
General disorders Oedema	5.4% 12/224 • Number of events 15 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	4.0% 9/224 • Number of events 9 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Blood and lymphatic system disorders Anaemia	10.3% 23/224 • Number of events 26 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	5.8% 13/224 • Number of events 16 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Blood and lymphatic system disorders Leukopenia	8.5% 19/224 • Number of events 29 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	6.7% 15/224 • Number of events 28 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Skin and subcutaneous tissue disorders Rash	7.6% 17/224 • Number of events 18 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	10.3% 23/224 • Number of events 31 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Skin and subcutaneous tissue disorders Acne	4.0% 9/224 • Number of events 11 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	5.4% 12/224 • Number of events 13 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Respiratory, thoracic and mediastinal disorders Cough	9.4% 21/224 • Number of events 23 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	13.4% 30/224 • Number of events 38 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Metabolism and nutrition disorders Hypokalaemia	8.9% 20/224 • Number of events 23 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	10.7% 24/224 • Number of events 36 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Vascular disorders Hypertension	8.9% 20/224 • Number of events 23 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	5.4% 12/224 • Number of events 14 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
Psychiatric disorders Insomnia	8.0% 18/224 • Number of events 19 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	4.5% 10/224 • Number of events 10 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/123 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.	0.00% 0/132 • All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period. All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.

Additional Information

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