Composition of the data monitoring committee and its role and reporting structure {21a}
The external DSMB is independent of the sponsor and competing interests. The DSMB will monitor and protect patient safety throughout the clinical trial, with an emphasis on progress, safety data and critical efficacy endpoints according to the DAMOCLES group. Members of the DSMB include two transplant nephrologists and one biostatistician. The DSMB will report to the steering committee, management team and sponsor. Details concerning the DSMB are outlined in the DSMB charter (not finalised yet).