Calmus 2010.

Methods	Randomised clinical trial
Participants	Country: France Period of recruitment: 2002‐2004 Number randomised: 207 Post‐randomisation dropouts: 8 (3.9%) Revised sample size: 199 Reasons for post‐randomisation dropouts: elevated serum creatinine, death, hepatic arterial thrombosis, retransplantation for non‐primary graft function, acute renal failure Average age (years): 53 Females: 48 (24.1%) Primary transplantation: 199 (100.0%) Reason for transplantation Alcohol‐related cirrhosis: 62 (31.2%) Viral‐related cirrhosis: 22 (11.1%) Autoimmune disease‐related cirrhosis: not stated HCC: 81 (40.7%) Others: 15 (7.5%) Maintenance immunosuppression used during induction immunosuppression: tacrolimus plus mycophenolate mofetil Altered immunosuppression after withdrawal: yes (mycophenolate was dropped). Glucocorticosteroids were also continued as part of maintenance immunosuppression Other exclusion criteria: multiorgan transplantation serum creatinine level more than 180 micromol/L at 12 hr post‐transplant ABO blood group incompatibility Positive for HIV
Interventions	Group 1: daclizumab + glucocorticosteroids (n = 98) Further details: daclizumab: first dose was 2.0 mg/kg administered at 12‐hr post‐transplant, the second dose was 1.0 mg/kg administered between days 7 and 10 + glucocorticosteroids were initiated at 15 to 20 mg/day until the end of month 1, decreased to 10 to 15 mg/day until the end of month 2, and then decreased to 5 to 10 mg/day for the remainder of the study Group 2: glucocorticosteroids (n = 101) Further details: glucocorticosteroids were initiated at 15 to 20 mg/day until the end of month 1, decreased to 10 to 15 mg/day until the end of month 2, and then decreased to 5 to 10 mg/day for the remainder of the study
Outcomes	Outcomes reported: mortality at maximal follow‐up, graft failure at maximal follow‐up, serious adverse events (number of people), any adverse events (number of people), liver transplantation at maximal follow‐up, graft rejection (any) Follow‐up (months): 24
Notes	Source of funding (quote): "The work was supported by Astellas Pharma, France" Trial name/trial registry number: not stated Attempts were made to contact the authors in August 2019.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Computer‐generated randomization was 1:1 and stratified according to the local center"
Allocation concealment (selection bias)	Low risk	Quote: "Sealed randomization envelopes were supplied by the study sponsor"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "randomized, open‐label, comparative study"
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "randomized, open‐label, comparative study"
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: there were post‐randomisation dropouts. These were probably related to the intervention and were likely to affect the outcomes
Selective reporting (reporting bias)	Low risk	Comment: no pre‐published protocol was available, but the authors reported on mortality, graft loss, and adverse events
Other bias	Low risk	Comment: no other bias noted