Sequence generation {16a}
CDMS
Randomization will be performed after the allocation of the graft or after the harvesting team has macroscopically assessed the graft, according to the center practice.It will be stratified by center and MELD score at the time of transplantation, with a cut-off of 30 (MELD < 30 versus MELD ≥ 30).The randomization process will be centralized and carried out via Ennov Clinical software. The randomization list will be drawn up by the methodologist/biostatistician of the Clinical Research Center at the Croix-Rousse University hospital, Lyon, France.The randomization list will be kept for 25 years in a tamper-proof envelope with the mandatory information (signature of the person in charge of the list, date and version number, complete title, and code of the research protocol). This list will also be sent to the Clinical Research Center data manager for implementation in the Ennov Clinical software.The investigator or a person designated by the principal investigator will randomize patients via the Ennov Clinical software. Only authorized persons will be able to perform the randomization. A confirmation email will be sent to the person who performed the randomization after each randomization, to the investigator associated with the patient, and to the management center.In case of cancellation of the transplant for any reasons, the data manager will cancel the randomization. The patient will remain included in the study for randomization in one of the study arms.The whole process (randomization, modifications, etc.) will be recorded in the audit trail of the study, which will be integrated in the clinical data management system (CDMS). This audit trail will be transmitted at the end of the study to be archived with all the study documents.