Reggiani 2005.

Methods	Trial design: randomised, single‐centre, open‐label clinical trial Mean follow‐up: 31 ± 7 months Study duration: not reported Language: English Type of information: journal article Judgement on quality: high risk
Participants	Setting: IRCCS Ospedale Maggiore, Milan, Italy Allocation of participants: 30 participants, 18 allocated to Intervention A, 12 allocated to Intervention B Sex ratio: total: 21 (70%) males, 9 (30%) females Intervention A: 13 (72.2%) males, 5 (27.8%) females Intervention B: 8 (66.7%) males, 4 (33.3%) females Mean age: total: not reported Intervention A: 50.4 ± 8.9 Intervention B: 49.7 ± 4.6 Indication (no. (%)): HCV or HBV cirrhosis: total: 21 (70.0%), Intervention A: 14 (77.8%), Intervention B: 7 (58.3%) Alcoholic cirrhosis: total: 3 (10.0%), Intervention A: 1 (5.6%), Intervention B: 2 (16.7%) Haemochromatosis: total: 2 (6.7%), Intervention A: 1 (5.6%), Intervention B: 1 (8.3%) Primary biliary cirrhosis: total: 1 (3.3%), Intervention A: 1 (5.6%), Intervention B: 0 (0.0%) Acute liver failure: total: 1 (3.3%), Intervention A: 1 (5.6%), Intervention B: 0 (0.0%) Cryptogenic cirrhosis: total: 1 (3.3%), Intervention A: 0 (0.0%), Intervention B: 1 (8.3%) Polycystic liver disease: total: 1 (3.3%), Intervention A: 0 (0.0%), Intervention B: 1 (8.3%) Type of donor: not reported Inclusion criteria: not reported Exclusion criteria: not reported Other: Hepatocellular carcinoma: total: 14 (46.7%), Intervention A: 12 (66.7%), Intervention B: 2 (16.7%)
Interventions	Intervention A: methylprednisolone: no intervention Intervention B: 1000 mg intraoperatively then 200 mg/day tapered to 40 mg/day at day 5, 20 mg on day 6 then tapered to stop at 3 months Concomitant immunosuppression: Tacrolimus: started at 0.1 mg/kg aiming for trough levels of 10 ng/mL to 15 ng/mL for 2 weeks then 8 ng/mL to 10 ng/mL thereafter Mycophenolate mofetil: 750 mg twice daily for 1 month, 500 mg twice daily thereafter
Outcomes	Mortality, surgical complications, tacrolimus levels, MMF levels, acute rejection, graft loss, infections, diarrhoea, "peptic symptoms", impaired renal function, leukopenia, thrombocytopenia, anaemia, neurotoxicity, diabetes mellitus, hypertension
Notes	Cross‐over between intervention arms: no Sample size calculation: not reported Sources of funding: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: Generation of randomisation sequence not described
Allocation concealment (selection bias)	Unclear risk	Comment: Allocation concealment not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote from the publication: "To assess the efficacy and safety or a primary immunosuppressive regimen with tacrolimus (Tac) and low‐dose mycophenolate mofetil (MMF) without steroids and to determine the exposure to mycophenolic acid (MPA) in the early post‐operative period, we performed a single‐center, randomized 1:1, open‐label, controlled study planned to be 60 liver transplantation patients randomized into 2 groups: group A, tacrolimus + MMF (750 mg orally twice a day); and group B, tacrolimus + MMF (750 mg orally twice a day) + steroids." Comment: Blinding of participants and medical staff not performed
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote from the publication: "To assess the efficacy and safety or a primary immunosuppressive regimen with tacrolimus (Tac) and low‐dose mycophenolate mofetil (MMF) without steroids and to determine the exposure to mycophenolic acid (MPA) in the early post‐operative period, we performed a single‐center, randomized 1:1, open‐label, controlled study planned to be 60 liver transplantation patients randomized into 2 groups: group A, tacrolimus + MMF (750 mg orally twice a day); and group B, tacrolimus + MMF (750 mg orally twice a day) + steroids." Comment: Blinding of outcome assessors not performed
Incomplete outcome data (attrition bias)	Unclear risk	Comment: Number of withdrawals and reasons for withdrawal not reported
Selective reporting (reporting bias)	Low risk	Comment: All specified outcomes appear to be reported
Other bias	Unclear risk	Comment: No sample size calculation reported
Free of early stopping?	High risk	Quote from the publication: "Patient enrollment was stopped after an interim analysis by the Ethical Committee." Comment: Study stopped early due to data dependent process (interim analysis)
Free of baseline imbalance?	High risk	Quote from the publication: "Hepatocellular carcinoma was diagnosed in 2 (16.7%) patients in group A and in 12 (66.7%) patients in group B." Comment: Significantly increased rates of pretransplant hepatocellular carcinoma in Intervention B