Stallone 2004.

Methods	Design: open‐label RCT Duration: enrolment from January 2000 Follow up: 12 months
Participants	Setting: single centre Country: Italy Kidney transplant recipients Number (group 1/group 2): 90 (42/48) Mean age ± SD (years): group 1 (50.4 ± 7.8); group 2 (51.8 ± 6.3) Sex (M/F): not reported Exclusions: not reported
Interventions	Treatment group 1 SRL: 15 mg, then 5 mg/d for trough levels 6 to 10 ng/mL CSA: 4 to 7 mg/kg/d for C2 levels 600 to 800 ng/mL; for DGF, CSA 3 to 5 mg/kg/d for C2 levels 400 to 600 ng/mL Treatment group 2 MMF: 2 g/d CSA: 10 mg/kg/d for C2 levels 1200 to 1400 ng/mL; for DGF, CSA C2 levels 800 to 1000 ng/mL Co‐interventions Basiliximab Prednisolone
Outcomes	Death (all causes) Graft loss censored for death Graft loss or death with a functioning graft Acute rejection CrCl SCr
Notes	Comparison: TOR‐I versus antimetabolite
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information to permit judgement
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcomes unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	All recipients accounted for
Selective reporting (reporting bias)	High risk	No report of adverse effects
Other bias	Unclear risk	Insufficient information to permit judgement