Ramirez 2013.

Methods	Trial design: randomised, single‐centre, open‐label clinical trial Mean follow‐up: 64.4 months (range: 10.6 to 79.6) Study duration: randomisation from February 2006 and November 2007 Language: English Type of information: journal article Judgement on quality: high risk
Participants	Setting: Division of Transplantation, Department of Surgery, Thomas Jefferson University, Philadelphia, USA Allocation of participants: 40 participants, 20 allocated to Intervention A, 20 allocated to Intervention B Sex ratio: total: 25 (62.5%) males, 15 (37.5%) females Intervention A: 12 (60%) males, 8 (40%) females Intervention B: 13 (65%) males, 7 (35%) females Mean age: total: not reported Intervention A: 48.1 ± 4.3 Intervention B: 45.5 ± 3.5 Indication (no. (%)): HCV cirrhosis: total: 25 (62.5%), Intervention A: 11 (55.0%), Intervention B: 14 (70.0%) HBV cirrhosis: total: 4 (10.0%), Intervention A: 2 (10.0%), Intervention B: 2 (10.0%) Primary sclerosing cholangitis: total: 2 (5.0%), Intervention A: 2 (10.0%), Intervention B: 0 (0%) Hepatocellular carcinoma: total: 21 (52.5%), Intervention A: 10 (50.0%), Intervention B: 11 (55.0%) Alcoholic cirrhosis: total: 9 (22.5%), Intervention A: 3 (15.0%), Intervention B: 6 (30.0%) Non‐alcoholic steatohepatitis: total: 1 (2.5%), Intervention A: 1 (5.0%), Intervention B: 0 (0%) Budd‐Chiari syndrome: total: 1 (2.5%), Intervention A: 0 (0%), Intervention B: 1 (5.0%) Cryptogenic cirrhosis: total: 3 (7.5%), Intervention A: 2 (10.0%), Intervention B: 1 (5.0%) Type of donor: deceased donors Inclusion criteria: first adult liver transplant, age 18 to 72, cold ischaemic time < 20 hours Exclusion criteria: positive pregnancy test, previous organ transplant, multiple organ transplant recipients, women of childbearing potential not using the prescribed contraceptive methods, known sensitivity to basiliximab or class of basiliximab, participants with severe medical condition(s) that in the view of the investigator prohibits participation in the study, and use of any other investigational agent within 30 days prior to enrolment Other: Pretransplant MELD: total: not reported, Intervention A: 23.2 ± 1.5, Intervention B: 24.4 ± 2.0
Interventions	Intervention A: no intervention Intervention B: methylprednisolone: 1000 mg intraoperatively, then tapered to 50 mg 6‐hourly on day 1, 40 mg 6‐hourly on day 2, 30 mg 6‐hourly on day 3, 20 mg 6‐hourly on day 4, 20 mg 12‐hourly on day 5 and then 20 mg once daily, tapered until stop at 6 months Concomitant immunosuppression: Tacrolimus: started at 0.1 mg/kg aiming for 8 ng/mL to 12 ng/mL for 1 month and then 5 ng/mL to 8 ng/mL thereafter Mycophenolate mofetil: 1000 mg every 12 hours via nasogastric tube until tolerating oral medication after which 720 mg enteric‐coated mycophenolate sodium twice daily orally for 3 months Basiliximab: 20 mg intraoperatively and on day 4 Prophylaxis: Ganciclovir or valganciclovir: 450 mg once daily for at least 3 months Trimethoprim sulfa: 3 times per week, dose and duration not reported Nystatin swish and swallow: 3 times daily, dose and duration not reported
Outcomes	Mortality, graft loss, acute rejection, infection, CMV infection, recurrent hepatitis C, severity of HCV recurrence, diabetes mellitus, hypertension, weight, cholesterol, mean arterial pressure, fasting blood glucose, ALT, AST, bilirubin
Notes	Cross‐over between intervention arms: no Sample size calculation: not reported Sources of funding: Novartis Corporation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from the publication: "Randomization was performed by the TJUH Investigational Drug Pharmacy Service who dispensed study drug based on the computer‐generated randomization schedule and the study protocol." 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: "Between February 2006 and November 2007, 40 adult recipients of deceased donor primary OLT at TJUH were enrolled into this prospective, controlled, randomized, non‐blinded, pilot trial (Clinical Trials.gov; ID: NCT00296244)." Comment: Blinding of participants and medical staff not performed
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote from the publication: "Between February 2006 and November 2007, 40 adult recipients of deceased donor primary OLT at TJUH were enrolled into this prospective, controlled, randomized, non‐blinded, pilot trial (Clinical Trials.gov; ID: NCT00296244)." Comment: Blinding of outcome assessors not performed
Incomplete outcome data (attrition bias)	Low risk	Quote from the publication: "Between February 2006 and November 2007, 40 adult OLT recipients were enrolled in the study and 20 recipients were randomized to each group. One recipient in the CS‐free group required a retransplantation for hepatic artery thrombosis on post‐OLT day 16. Because he expired within 10 d after retransplantation, follow‐up data were short and untenable, and therefore, he was excluded from the study analysis (Fig. 1)." Comment: One withdrawal and reason for the withdrawal adequately described
Selective reporting (reporting bias)	Low risk	Comment: All outcomes appear to be fully reported
Other bias	High risk	Quote from the publication: "The authors would like to acknowledge Novartis Corporation for providing financial grant to conduct the clinical trial." Comment: No sample size calculation reported; study is industry sponsored
Free of early stopping?	Low risk	Comment: Study not stopped early
Free of baseline imbalance?	Low risk	Quote from the publication: "Donor characteristics were comparable between the two groups (Table 1). Other than a significantly higher mean recipient age and longer median hospital stay in CS‐free (23 d) compared with CS group (15 d), recipient demographics and peri‐operative data were similar between the two groups." Comment: Baseline imbalance is unlikely to significantly affect outcomes