ter Meulen 2002.

Methods	Multicentre RCT Duration: October 1999 to March 2002 Stratified by centre
Participants	Country: The Netherlands First (89%) or subsequent, cadaveric (64%) or living donor kidney transplant Median age (range) Treatment group: 48 (18‐78) Control group: 49 (19‐73) Number (treatment/control): 381 enrolled, 364 analysed (86/178) Sex (% male) Treatment group: 72% Control group: 57% Exclusions: HLA‐identical living donor; taking immunosuppressive medication; haemolytic uraemic syndrome; premenopausal women not taking adequate contraception; leukocytopenia or thrombocytopenia
Interventions	Treatment group Daclizumab: 1 mg/kg days 0 and 14 Control group Steroids: 0.3 mg/kg/d for first 2 weeks then dose tapered to zero in 4 months Baseline immunosuppression TAC: 0.3 mg/d and adjust to trough levels 15‐20 ng/mL (days 0‐14), 10‐15 ng/mL (weeks 3‐6) and 5‐10 ng/mL after week 7 MMF: 2 g/d for 2 weeks then reduced to 1.5 g/d Steroids: All patients received 100 mg IV for first 3 days
Outcomes	Mortality Graft loss Acute rejection Delayed Graft Function Infection Malignancy Adverse reaction
Notes	12 months follow‐up
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Stated "randomly assigned" but no further information provided
Allocation concealment (selection bias)	Low risk	“randomisation was carried out by opening a sealed opaque envelope with the lowest available study number at each participating centre”
Blinding (performance bias and detection bias) Objective outcomes	High risk	“both clinicians and patients were aware of the randomised assignment”, blinding of outcome assessors not stated
Blinding (performance bias and detection bias) Subjective outcomes	High risk	“both clinicians and patients were aware of the randomised assignment”, blinding of outcome assessors not stated
Incomplete outcome data (attrition bias) All outcomes	Low risk	Yes, ITT analysis reported, all patients followed up or accounted for (3 patients lost to follow up at 12 months)
Selective reporting (reporting bias)	Low risk	Primary outcomes for this review (death, graft loss and acute rejection) were reported
Other bias	High risk	Supported by grants from Roche Pharmaceuticals, Mijdrecht, and Fujisawa, Houten