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. 2020 Jan 16;2020(1):CD013203. doi: 10.1002/14651858.CD013203.pub2

Neumann 2012.

Methods Randomised clinical trial
Participants Country: multicentric (Europe)
 Period of recruitment: 2005‐2008
 Number randomised: 138
 Post‐randomisation dropouts: 3 (2.2%)
 Revised sample size: 135
 Reasons for post‐randomisation dropouts: not transplanted or no study medication
 Average age (years): 54
 Females: 41 (30.4%)
 Primary transplantation: 135 (100.0%)
 Reason for transplantation
Alcohol‐related cirrhosis: 0 (0.0%)
 Viral‐related cirrhosis: 135 (100.0%)
 Autoimmune disease‐related cirrhosis: 0 (0.0%)
 HCC: 0 (0.0%)
 Others: 0 (0.0%)
 Maintenance immunosuppression used during induction immunosuppression: tacrolimus
 Altered immunosuppression after withdrawal: no
Interventions Group 1: daclizumab (n = 67)
 Further details: daclizumab 2 mg/kg two doses: the first dose was given during the anhepatic period and the second dose between days 7 and 10
 Group 2: glucocorticosteroids (n = 68)
 Further details: glucocorticosteroids (no further details) were given at a bolus dose of 500 mg in the perioperative period followed by tapered doses of 15‐20 mg/day during month 1, 10‐15 mg/day during month 2, 5‐10 mg/day during month 3, then discontinued
Outcomes Outcomes reported: mortality at maximal follow‐up, graft failure at maximal follow‐up, any adverse events (number of people), graft rejection (any), graft rejection (requiring treatment)
 Follow‐up (months): 12
Notes Source of funding (quote): "Astellas Pharma Europe Ltd. provided funding for the study"
 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: "RANCODE (version 3.6) was used to generate the randomization sequence"
Allocation concealment (selection bias) Low risk Quote: "Allocation to treatment arms was performed using sealed sequentially numbered randomization envelopes provided by the study sponsor"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "prospective, randomized, open‐label, parallel arm study"
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "prospective, randomized, open‐label, parallel arm study"
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: there were post‐randomisation dropouts. It was not clear whether these could be related to the interventions
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