Selected secondary endpoints
death, BANFF, tremor, infections, BPAR, hyperglycaemia
POST-TRANSPLANT DIABETES MELLITUS, INFECTIONS, BLIND, HYPERGLYCAEMIA, PATHOLOGY

Number of IMP dose adjustments until 12 weeksTime (days) to reach the first defined range in target trough level, utilising the date of first in-range reading of two consecutive readings within the rangeNumber of measurements above and below the first defined range in target trough levelC/D ratio measured at 1, 2 and 3 yearsMean tacrolimus trough level and inter-patient variability (range) of tacrolimus trough levels at 1, 2, 4 and 12 weeksInter-patient variability (range) of tacrolimus total daily dose until 12 weeksProportion of patients with trough levels lower, within, or higher than the standard reference range at 1, 2, 4 and 12 weeksIncidence and severity (BANFF criteria) of clinically confirmed biopsy-proven rejection (BPAR) at 12 weeks and 1, 2, 3 yearsIncidence of graft failure (defined as necessity for re-transplantation) at 12 weeks and 1, 2, 3 yearsIncidence of death (for any reason) at 12 weeks and 1, 2, 3 yearsLaboratory measures of liver function, renal function and metabolism at 12 weeks and 1, 2, 3 yearsMalignancies and infections at 1, 2 and 3 yearsIncidence of de novo occurrence of tremor or vision impairmentsIncidence of post-transplant diabetes mellitus and post-transplant hyperglycaemia at 12 weeks and 1, 2, 3 yearsGraft biopsies are read at each site by the local pathologist. The local assessment will be used to guide the clinical treatment of the patient during the study. A diagnosis of BPAR is based on histological grading using the BANFF criteria for hepatic allograft pathology. In addition, a central assessment of biopsy pathology will be conducted by an independent central pathologist who is blind to the treatment assignment. To avoid detection bias, the blinded central assessment will be taken as the official result for the trial and for the determination of the BPAR endpoint.