Tisone 1999.

Methods	Trial design: randomised, single‐centre, open‐label clinical trial Mean follow‐up: 108 ± 4 months Study duration: 10 years from randomisation Language: English Type of information: journal article Judgement on quality: high risk
Participants	Setting: Ospedale S. Eugenio, Piazzale dell'Umanesimo, Rome, Italy Allocation of participants: 45 participants, 22 allocated to Intervention A, 23 allocated to Intervention B Sex ratio: total: 34 (75.6%) males, 11 (24.4%) females Intervention A: 16 (72.7%) males, 6 (26.1%) females Intervention B: 18 (72%) males, 5 (21.7%) females Mean age: total: not reported Intervention A: 49.0 ± 9.8 Intervention B: 50.5 ± 6.2 Indication (no. (%)): HCV cirrhosis: total: 15 (33.3%), Intervention A: 8 (36.4%), Intervention B: 7 (30.4%) HBV cirrhosis: total: 13 (28.9%), Intervention A: 7 (31.8%), Intervention B: 6 (26.1%) Alcoholic cirrhosis: total: 6 (13.3%), Intervention A: 2 (9.1%), Intervention B: 4 (17.4%) Cryptogenic cirrhosis and others: total: 11 (24.4%), Intervention A: 5 (22.7%), Intervention B: 6 (26.1%) Type of donor: not reported Inclusion criteria: adult liver transplant recipients (> 20 years of age and < 62), HBsAg‐positive participants were only considered for inclusion if repeatedly HBV‐DNA negative Exclusion criteria: positive HIV serology, positive for IgM anti‐cytomegalovirus, HBV‐DNA‐positive participants Other: Donor age: total: not reported, Intervention A: 38.3 ± 14, Intervention B: 35.3 ± 16 Donor sex ratio: total: 30 (66.7%) male, 15 (33.3%) female; Intervention A: 13 (59.1%) males, 9 (39.1%) females; Intervention A: 17 (73.9%) males, 6 (26.1%) females Cold ischaemia time (hours): total: not reported, Intervention A: 6.2+/‐2.8, Intervention B: 6.4+/‐1.8 Possible selective outcome reporting: hypertension is not reported in any of the relevant publications
Interventions	Intervention A: No intervention Intervention B: Methylprednisolone: 20 mg/day (duration not reported) Prednisone: (starting from withdrawal of methylprednisolone) 20 mg/day until day 30 then tapered "gradually" to 5 mg/day and stopped at 3 months Concomitant immunosuppression: Cyclosporine A: aiming for trough levels of 350 ng/mL to 450 ng/mL for "the first few months" then 250 ng/mL to 350 ng/mL thereafter Azathioprine: 1 to 1.5 mg/day (duration not reported)
Outcomes	Mortality, graft loss, acute rejection, primary non‐function, poor initial function, normal function, chronic rejection, infection, CMV infection, recurrent hepatitis C, renal failure (requiring dialysis), AST, bilirubin, alkaline phosphatase, GGT, creatinine, cyclosporine serum levels, time in intensive treatment unit, time in hospital, glucose, cholesterol
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)	Low risk	Quote from the publication: "Patients were randomly assigned, using a computer‐generated list, to receive a standard immunosuppressive therapy composed of cyclosporine microemulsion (Neoral), in doses to maintain trough whole‐blood levels (monoclonal fluorescence assay) of 350‐450 ng/ml during the first months and 250‐350 ng/ml thereafter, and azathioprine (1‐1.5 mg/day), with (group A) or without (group B) corticosteroids." Comment: Computer‐generated randomisation
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 address the latter points, we conducted a prospective open‐label randomized pilot study on a consecutive series of patients undergoing orthotopic liver transplantation (OLTx) at our institution." Comment: Blinding of participants and medical staff not performed
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote from the publication: "To address the latter points, we conducted a prospective open‐label randomized pilot study on a consecutive series of patients undergoing orthotopic liver transplantation (OLTx) at our institution." 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)	Unclear risk	Comment: Study does not report hypertension despite mentioning this as a potential complication of glucocorticosteroid use in both the introduction and the discussion sections
Other bias	Unclear risk	Comment: No sample size calculation reported
Free of early stopping?	Low risk	Comment: Study not stopped early
Free of baseline imbalance?	Low risk	Quote from the publication: "As summarized in Table 1, the two groups did not differ in the demographic or clinical features of donors and recipients, or in the duration of cold ischemia. In particular, there were no differences in the UNOS status or in the hemodynamic data and the laboratory findings related to liver and kidney function between the two groups." Comment: Study free from baseline imbalance