Visit 1—Baseline
Blood coagulation
At the baseline visit (visit 1), patients are randomised and baseline characteristics are measured. The date of the baseline visit is designated as trial “day 0” and must occur no later than 14 days after transplantation surgery.In case the run-in phase is skipped, all screening procedures must be performed at the baseline visit prior to randomisation. Randomisation may take place only after all eligibility criteria have been checked and fulfilled.The following baseline procedures/data will be performed/collected (the applicable panel of assessments is displayed in Fig. Randomisation, dispensing of assigned IMP, explaining practicalities of drug administration to the patientPatient characteristics, including demographicsPast medical historyDonor and transplantation dataPhysical examination, including body weight12-lead ECGVital signs: blood pressure, pulse rate, body temperatureBlood sampling for clinical tests:◦ Haematology, serum biochemistry, including calculation of eGFR◦ Blood coagulation screen◦ Virology status: CMV, EBV, HCV, HBV◦ Tacrolimus trough level (if immediate-release tacrolimus given prior to randomisation)Urine sampling for clinical urine analysisReview and documentation of concomitant medication that interacts with IMP or is prohibited per protocolSchedule of clinical assessments