Trial Outcomes & Findings for Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension (NCT NCT03781414)

Last Updated: 2025-05-16

Results Overview

The occurrence of biopsy proven acute rejection (BPAR) was evaluated based on central pathologist evaluation. Graft loss and death was evaluated as per local evaluation.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

129 participants

Primary outcome timeframe

Baseline to Month 12

Results posted on

2025-05-16

Participant Flow

The patients were enrolled at 3 sites in Argentina, 1 in Belgium, 1 in Czech Republic, 4 in France, 4 in Germany, 1 in Hungary, 1 in Italy, 1 in The Netherlands, 4 in Spain and 9 in United States.

Patients were randomized at a ratio of 2:3:3 to TAC Control (Arm 1) or one of two maintenance regimens of CFZ533: 600 mg CFZ533 subcutaneous (SC) injections every 2 weeks (Arm 2) or 300 mg CFZ533 SC injections every 2 weeks (Arm 3) combined with MMF and CS.

Participant milestones

Participant milestones
Measure	CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) Single loading dose of 30 mg/kg IV on Day 8 (with +/- 2 days window). The SC administration of 300 mg (1 injection of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) Loading doses of 30 mg/kg IV on Day 8 (with +/- 2 days window), and 15 mg/kg IV on Day 15. The subcutaneous (SC) administration of 600 mg (2 injections of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	TAC Control (TAC + MMF) Tacrolimus (TAC) + Mycophenolate mofetil (MMF) + Corticosteroids (CS) up to End of Study (EOS). Initial TAC target trough were between 5-15 ng/mL during the run-in period. From randomization onwards, the TAC levels were adjusted as per local label.
Overall Study STARTED	48	48	32
Overall Study Safety Set (SAF)	48	47	32
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	48	48	32

Reasons for withdrawal

Reasons for withdrawal
Measure	CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) Single loading dose of 30 mg/kg IV on Day 8 (with +/- 2 days window). The SC administration of 300 mg (1 injection of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) Loading doses of 30 mg/kg IV on Day 8 (with +/- 2 days window), and 15 mg/kg IV on Day 15. The subcutaneous (SC) administration of 600 mg (2 injections of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	TAC Control (TAC + MMF) Tacrolimus (TAC) + Mycophenolate mofetil (MMF) + Corticosteroids (CS) up to End of Study (EOS). Initial TAC target trough were between 5-15 ng/mL during the run-in period. From randomization onwards, the TAC levels were adjusted as per local label.
Overall Study Study terminated by sponsor	39	34	25
Overall Study Adverse Event	3	6	3
Overall Study Physician Decision	2	0	1
Overall Study Withdrawal by Subject	2	3	3
Overall Study Death	1	4	0
Overall Study Lost to Follow-up	1	1	0

Baseline Characteristics

Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) n=48 Participants Single loading dose of 30 mg/kg IV on Day 8 (with +/- 2 days window). The SC administration of 300 mg (1 injection of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) n=48 Participants Loading doses of 30 mg/kg IV on Day 8 (with +/- 2 days window), and 15 mg/kg IV on Day 15. The subcutaneous (SC) administration of 600 mg (2 injections of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	TAC Control (TAC + MMF) n=32 Participants Tacrolimus (TAC) + Mycophenolate mofetil (MMF) + Corticosteroids (CS) up to End of Study (EOS). Initial TAC target trough were between 5-15 ng/mL during the run-in period. From randomization onwards, the TAC levels were adjusted as per local label.	Total n=128 Participants Total of all reporting groups
Age, Continuous	56.7 Years STANDARD_DEVIATION 9.94 • n=5 Participants	56.2 Years STANDARD_DEVIATION 6.98 • n=7 Participants	54.0 Years STANDARD_DEVIATION 9.90 • n=5 Participants	55.8 Years STANDARD_DEVIATION 8.92 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	15 Participants n=7 Participants	8 Participants n=5 Participants	34 Participants n=4 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	33 Participants n=7 Participants	24 Participants n=5 Participants	94 Participants n=4 Participants
Race/Ethnicity, Customized White	45 Participants n=5 Participants	46 Participants n=7 Participants	29 Participants n=5 Participants	120 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Month 12

Population: Full Analysis Set (FAS)

The occurrence of biopsy proven acute rejection (BPAR) was evaluated based on central pathologist evaluation. Graft loss and death was evaluated as per local evaluation.

Outcome measures

Outcome measures
Measure	CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) n=48 Participants Single loading dose of 30 mg/kg IV on Day 8 (with +/- 2 days window). The SC administration of 300 mg (1 injection of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) n=48 Participants Loading doses of 30 mg/kg IV on Day 8 (with +/- 2 days window), and 15 mg/kg IV on Day 15. The subcutaneous (SC) administration of 600 mg (2 injections of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	TAC Control (TAC + MMF) n=32 Participants Tacrolimus (TAC) + Mycophenolate mofetil (MMF) + Corticosteroids (CS) up to End of Study (EOS). Initial TAC target trough were between 5-15 ng/mL during the run-in period. From randomization onwards, the TAC levels were adjusted as per local label.
Percentage of Patients With Composite Event (Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death) Over 12 Months	8 Participants	12 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline to Month 12

Population: Full Analysis Set (FAS)

Renal function as measured by estimated Glomerular Filtration Rate (eGFR) was evaluated using the MDRD formula: eGFR = 175 x (serum concentration of creatinine (SCr))-1.154 x (age)-0.203 x 0.742 \[if female\] x 1.212 \[if Black\].

Outcome measures

Outcome measures
Measure	CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) n=48 Participants Single loading dose of 30 mg/kg IV on Day 8 (with +/- 2 days window). The SC administration of 300 mg (1 injection of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) n=48 Participants Loading doses of 30 mg/kg IV on Day 8 (with +/- 2 days window), and 15 mg/kg IV on Day 15. The subcutaneous (SC) administration of 600 mg (2 injections of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	TAC Control (TAC + MMF) n=32 Participants Tacrolimus (TAC) + Mycophenolate mofetil (MMF) + Corticosteroids (CS) up to End of Study (EOS). Initial TAC target trough were between 5-15 ng/mL during the run-in period. From randomization onwards, the TAC levels were adjusted as per local label.
Mean Change in Estimated Glomerular Filtration Rate (eGFR) From Randomization to Month 12	2.05 mL/min/1.73 m^2 Interval -60.4 to 71.5	-9.31 mL/min/1.73 m^2 Interval -55.8 to 28.7	-14.74 mL/min/1.73 m^2 Interval -104.0 to 20.6

SECONDARY outcome

Timeframe: Baseline up to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks.

Population: Safety Set (SAF)

The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs), Deaths due to AEs and TEAEs leading to discontinuation, through the monitoring of relevant clinical and laboratory safety parameters.

Outcome measures

Outcome measures
Measure	CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) n=48 Participants Single loading dose of 30 mg/kg IV on Day 8 (with +/- 2 days window). The SC administration of 300 mg (1 injection of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) n=47 Participants Loading doses of 30 mg/kg IV on Day 8 (with +/- 2 days window), and 15 mg/kg IV on Day 15. The subcutaneous (SC) administration of 600 mg (2 injections of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	TAC Control (TAC + MMF) n=32 Participants Tacrolimus (TAC) + Mycophenolate mofetil (MMF) + Corticosteroids (CS) up to End of Study (EOS). Initial TAC target trough were between 5-15 ng/mL during the run-in period. From randomization onwards, the TAC levels were adjusted as per local label.
Number of Participants With Treatment Emergent Adverse Events TEAEs	48 Participants	44 Participants	32 Participants
Number of Participants With Treatment Emergent Adverse Events TESAEs	30 Participants	29 Participants	20 Participants
Number of Participants With Treatment Emergent Adverse Events Fatal TESAEs	1 Participants	4 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events TEAEs leading to discontinuation	14 Participants	17 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline to Month 24

Population: Safety Set (SAF)

The number and percentage of participants with dose changes (MMF and TAC), dose interruptions (only in cases of ascites drainage), and permanent discontinuation was summarized. In the CFZ533 arms, during the immediate peri and post-transplant period, TAC was given to provide immunological coverage but TAC needed to be completely weaned off by Day 22.

Outcome measures

Outcome measures
Measure	CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) n=48 Participants Single loading dose of 30 mg/kg IV on Day 8 (with +/- 2 days window). The SC administration of 300 mg (1 injection of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) n=47 Participants Loading doses of 30 mg/kg IV on Day 8 (with +/- 2 days window), and 15 mg/kg IV on Day 15. The subcutaneous (SC) administration of 600 mg (2 injections of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	TAC Control (TAC + MMF) n=32 Participants Tacrolimus (TAC) + Mycophenolate mofetil (MMF) + Corticosteroids (CS) up to End of Study (EOS). Initial TAC target trough were between 5-15 ng/mL during the run-in period. From randomization onwards, the TAC levels were adjusted as per local label.
Percentage of Patients With Dose Interruptions and Permanent Discontinuation of Study Treatment CFZ533: Subjects with dose interrupted	8 Participants	5 Participants	—
Percentage of Patients With Dose Interruptions and Permanent Discontinuation of Study Treatment CFZ533: Subjects with permanent discontinuation of study treatment	2 Participants	3 Participants	—
Percentage of Patients With Dose Interruptions and Permanent Discontinuation of Study Treatment TAC: Subjects with dose interrupted	3 Participants	3 Participants	6 Participants
Percentage of Patients With Dose Interruptions and Permanent Discontinuation of Study Treatment TAC: Subjects with permanent discontinuation of study treatment	4 Participants	8 Participants	4 Participants
Percentage of Patients With Dose Interruptions and Permanent Discontinuation of Study Treatment MMF: Subjects with dose interrupted	18 Participants	23 Participants	15 Participants
Percentage of Patients With Dose Interruptions and Permanent Discontinuation of Study Treatment MMF: Subjects with permanent discontinuation of study treatment	9 Participants	5 Participants	1 Participants

POST_HOC outcome

Timeframe: On-treatment deaths: Up to approximately 184 weeks. Post-treatment deaths: Up to approximately 184 weeks.

Population: Safety Set (SAF)

On-treatment deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants, Arms 2 \& 3) and from 13 weeks for TAC participants (Arm 1), up to approx. 184 weeks. These are not considered Adverse Events.

Outcome measures

Outcome measures
Measure	CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) n=48 Participants Single loading dose of 30 mg/kg IV on Day 8 (with +/- 2 days window). The SC administration of 300 mg (1 injection of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) n=47 Participants Loading doses of 30 mg/kg IV on Day 8 (with +/- 2 days window), and 15 mg/kg IV on Day 15. The subcutaneous (SC) administration of 600 mg (2 injections of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	TAC Control (TAC + MMF) n=32 Participants Tacrolimus (TAC) + Mycophenolate mofetil (MMF) + Corticosteroids (CS) up to End of Study (EOS). Initial TAC target trough were between 5-15 ng/mL during the run-in period. From randomization onwards, the TAC levels were adjusted as per local label.
All Collected Deaths On-treatment deaths	1 Participants	3 Participants	0 Participants
All Collected Deaths Post-treatment deaths	0 Participants	1 Participants	0 Participants
All Collected Deaths All deaths	1 Participants	4 Participants	0 Participants

Adverse Events

CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) (On-Treatment)

Serious events: 30 serious events

Other events: 45 other events

Deaths: 1 deaths

CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) (On-Treatment)

Serious events: 29 serious events

Other events: 42 other events

Deaths: 3 deaths

TAC Control (TAC + MMF) (On-Treatment)

Serious events: 20 serious events

Other events: 30 other events

Deaths: 0 deaths

CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) (Post-Treatment)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) (Post-Treatment)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

TAC Control (TAC + MMF) (Post-Treatment)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) (On-Treatment) n=48 participants at risk Single loading dose of 30 mg/kg IV on Day 8 (with +/- 2 days window). The subcutaneous (SC) administration of 300 mg (1 injection of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) (On-Treatment) n=47 participants at risk Loading doses of 30 mg/kg IV on Day 8 (with +/- 2 days window), and 15 mg/kg IV on Day 15. The SC administration of 600 mg (2 injections of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	TAC Control (TAC + MMF) (On-Treatment) n=32 participants at risk Tacrolimus (TAC) + Mycophenolate mofetil (MMF) + Corticosteroids (CS) up to End of Study (EOS). Initial TAC target trough were between 5-15 ng/mL during the run-in period. From randomization onwards, the TAC levels were adjusted as per local label.	CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) (Post-Treatment) Deaths collected in the post- treatment follow-up period (starting 15 weeks after last dose of study medication (CFZ533 participants, Arms 2 \& 3) and until 13 weeks for TAC participants (Arm 1)). No AEs were collected during this period.	CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) (Post-Treatment) Deaths collected in the post- treatment follow-up period (starting 15 weeks after last dose of study medication (CFZ533 participants, Arms 2 \& 3) and until 13 weeks for TAC participants (Arm 1)). No AEs were collected during this period.	TAC Control (TAC + MMF) (Post-Treatment) Deaths collected in the post- treatment follow-up period (starting 15 weeks after last dose of study medication (CFZ533 participants, Arms 2 \& 3) and until 13 weeks for TAC participants (Arm 1)). No AEs were collected during this period.
Blood and lymphatic system disorders Febrile neutropenia	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Blood and lymphatic system disorders Leukopenia	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Blood and lymphatic system disorders Neutropenia	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Cardiac disorders Arteriosclerosis coronary artery	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Cardiac disorders Atrioventricular block	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Cardiac disorders Sinus arrhythmia	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Cardiac disorders Tachycardia	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain upper	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Appendicitis noninfective	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Ascites	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Diaphragmatic hernia	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Enteritis	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Gastritis	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Haematochezia	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Ileus	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Incarcerated umbilical hernia	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Inguinal hernia strangulated	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Large intestine perforation	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Pancreatitis acute	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Salivary gland calculus	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Salivary gland enlargement	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Varices oesophageal	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Vomiting	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
General disorders Chest pain	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
General disorders Multiple organ dysfunction syndrome	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
General disorders Pyrexia	10.4% 5/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	10.6% 5/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Bile duct stenosis	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Biliary ischaemia	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Biliary obstruction	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Biliary tract disorder	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Biloma	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Cholangitis	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Cholangitis acute	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Hepatic artery stenosis	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Hepatic artery thrombosis	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Hepatic function abnormal	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Hepatic haematoma	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Hepatic haemorrhage	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Hepatic mass	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Hepatitis cholestatic	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Hyperbilirubinaemia	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Jaundice	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Immune system disorders Graft versus host disease	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Immune system disorders Liver transplant rejection	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Immune system disorders Transplant rejection	8.3% 4/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Abscess	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Arthritis bacterial	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations COVID-19	8.3% 4/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations COVID-19 pneumonia	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Clostridium difficile colitis	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Cytomegalovirus colitis	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Cytomegalovirus hepatitis	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Cytomegalovirus infection	6.2% 3/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Cytomegalovirus infection reactivation	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Cytomegalovirus viraemia	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Endophthalmitis	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Enterococcal infection	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Escherichia sepsis	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Herpes zoster disseminated	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Liver abscess	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Oral herpes	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Peritonitis	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Peritonitis bacterial	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Pneumocystis jirovecii pneumonia	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Pneumonia	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Pneumonia cytomegaloviral	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Pyelonephritis	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Sepsis	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Septic shock	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Subcutaneous abscess	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Toxoplasmosis	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Urinary tract infection	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Wound infection	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Anastomotic stenosis	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Biliary anastomosis complication	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Complications of transplanted liver	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Fall	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Femoral neck fracture	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Graft loss	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Incisional hernia	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Liver transplant failure	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Peripancreatic fluid collection	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Post procedural bile leak	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Seroma	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Stress fracture	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Toxicity to various agents	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Investigations Blood alkaline phosphatase increased	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Investigations Carbohydrate antigen 19-9 increased	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Investigations Hepatic enzyme increased	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.4% 3/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Investigations Liver function test abnormal	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Investigations Liver function test increased	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant peritoneal neoplasm	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Nervous system disorders Ischaemic stroke	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Nervous system disorders Lethargy	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Nervous system disorders Tremor	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Product Issues Device dislocation	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Psychiatric disorders Hallucination	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Psychiatric disorders Mental status changes	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Psychiatric disorders Suicide attempt	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Renal and urinary disorders Acute kidney injury	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Renal and urinary disorders Renal cyst ruptured	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Vascular disorders Circulatory collapse	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Vascular disorders Haematoma	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Vascular disorders Hypotension	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.

Other adverse events

Other adverse events
Measure	CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) (On-Treatment) n=48 participants at risk Single loading dose of 30 mg/kg IV on Day 8 (with +/- 2 days window). The subcutaneous (SC) administration of 300 mg (1 injection of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) (On-Treatment) n=47 participants at risk Loading doses of 30 mg/kg IV on Day 8 (with +/- 2 days window), and 15 mg/kg IV on Day 15. The SC administration of 600 mg (2 injections of 2 mL CFZ533 at 150 mg/mL) every 2 weeks started on Day 29, in combination with MMF and CS up to EOS.	TAC Control (TAC + MMF) (On-Treatment) n=32 participants at risk Tacrolimus (TAC) + Mycophenolate mofetil (MMF) + Corticosteroids (CS) up to End of Study (EOS). Initial TAC target trough were between 5-15 ng/mL during the run-in period. From randomization onwards, the TAC levels were adjusted as per local label.	CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) (Post-Treatment) Deaths collected in the post- treatment follow-up period (starting 15 weeks after last dose of study medication (CFZ533 participants, Arms 2 \& 3) and until 13 weeks for TAC participants (Arm 1)). No AEs were collected during this period.	CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) (Post-Treatment) Deaths collected in the post- treatment follow-up period (starting 15 weeks after last dose of study medication (CFZ533 participants, Arms 2 \& 3) and until 13 weeks for TAC participants (Arm 1)). No AEs were collected during this period.	TAC Control (TAC + MMF) (Post-Treatment) Deaths collected in the post- treatment follow-up period (starting 15 weeks after last dose of study medication (CFZ533 participants, Arms 2 \& 3) and until 13 weeks for TAC participants (Arm 1)). No AEs were collected during this period.
Blood and lymphatic system disorders Anaemia	8.3% 4/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	10.6% 5/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	12.5% 4/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Blood and lymphatic system disorders Leukopenia	35.4% 17/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	34.0% 16/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	28.1% 9/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Blood and lymphatic system disorders Lymphopenia	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	10.6% 5/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Blood and lymphatic system disorders Neutropenia	29.2% 14/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	21.3% 10/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	12.5% 4/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.4% 3/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	9.4% 3/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Cardiac disorders Palpitations	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Cardiac disorders Tachycardia	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	8.5% 4/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Eye disorders Vision blurred	6.2% 3/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Abdominal distension	12.5% 6/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	9.4% 3/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain	10.4% 5/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	14.9% 7/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	25.0% 8/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain upper	10.4% 5/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	10.6% 5/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Ascites	16.7% 8/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	9.4% 3/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Constipation	12.5% 6/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	8.5% 4/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	12.5% 4/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	25.0% 12/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	17.0% 8/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	28.1% 9/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Intra-abdominal fluid collection	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Nausea	16.7% 8/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	8.5% 4/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	15.6% 5/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Vomiting	14.6% 7/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.4% 3/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	12.5% 4/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
General disorders Asthenia	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	9.4% 3/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
General disorders Fatigue	10.4% 5/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	10.6% 5/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	15.6% 5/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
General disorders Oedema peripheral	25.0% 12/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	12.8% 6/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	12.5% 4/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
General disorders Peripheral swelling	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
General disorders Pyrexia	14.6% 7/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	17.0% 8/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	15.6% 5/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Bile duct stenosis	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	8.5% 4/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Cholangitis	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Hepatobiliary disorders Portal vein stenosis	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Immune system disorders Liver transplant rejection	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations COVID-19	31.2% 15/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	31.9% 15/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	25.0% 8/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Cellulitis	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Cystitis	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	9.4% 3/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Cytomegalovirus infection	16.7% 8/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	10.6% 5/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	12.5% 4/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Cytomegalovirus infection reactivation	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	10.6% 5/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Cytomegalovirus viraemia	10.4% 5/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	12.8% 6/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Nasopharyngitis	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.4% 3/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Oral herpes	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Sinusitis	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Upper respiratory tract infection	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Urinary tract infection	8.3% 4/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	8.5% 4/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	21.9% 7/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Contusion	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Injury, poisoning and procedural complications Overdose	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Investigations Alanine aminotransferase increased	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.4% 3/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Investigations Blood alkaline phosphatase increased	12.5% 6/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	12.8% 6/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Investigations Blood creatinine increased	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	12.5% 4/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Investigations Gamma-glutamyltransferase increased	8.3% 4/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Investigations Hepatic enzyme increased	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	8.5% 4/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Investigations Liver function test increased	16.7% 8/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	8.5% 4/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Investigations Weight increased	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.4% 3/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Cell death	6.2% 3/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Decreased appetite	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.4% 3/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hyperglycaemia	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hyperkalaemia	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	12.5% 4/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	12.8% 6/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hypoglycaemia	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	9.4% 3/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	8.3% 4/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.4% 3/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Hypomagnesaemia	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.4% 3/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Iron deficiency	6.2% 3/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	18.8% 9/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	12.8% 6/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	16.7% 8/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	10.6% 5/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	12.5% 4/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.4% 3/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Nervous system disorders Headache	10.4% 5/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	21.3% 10/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	21.9% 7/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Nervous system disorders Syncope	8.3% 4/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Nervous system disorders Tremor	10.4% 5/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	12.8% 6/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	21.9% 7/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Psychiatric disorders Alcoholism	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.4% 3/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Psychiatric disorders Anxiety	10.4% 5/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.4% 3/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Psychiatric disorders Insomnia	12.5% 6/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.4% 3/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	9.4% 3/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Renal and urinary disorders Acute kidney injury	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	9.4% 3/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Renal and urinary disorders Dysuria	8.3% 4/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Renal and urinary disorders Haematuria	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Renal and urinary disorders Proteinuria	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.1% 1/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Renal and urinary disorders Urinary incontinence	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.2% 2/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	14.6% 7/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	10.6% 5/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.3% 4/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	10.6% 5/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	9.4% 3/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.4% 5/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	9.4% 3/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	9.4% 3/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Night sweats	2.1% 1/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.4% 3/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	4.2% 2/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	12.5% 4/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash	6.2% 3/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	10.6% 5/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Vascular disorders Hypertension	6.2% 3/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	6.4% 3/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	18.8% 6/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Vascular disorders Hypotension	6.2% 3/48 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.3% 2/47 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.1% 1/32 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	— 0/0 • On-treatment adverse events and deaths were reported from first dose of study treatment to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. Post-treatment deaths were collected in the post treatment period from 15 weeks after last dose of study medication (CFZ533 participants) and from 13 weeks for TAC participants, up to approx. 184 weeks. These are not considered Adverse Events. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER