Confidentiality
All study documents are provided by the sponsor to the investigator and the appointed staff in confidence. Trial materials may not be disclosed to any party not directly involved in the study without written permission from the sponsor.Each participant is assigned a unique patient trial identifier upon randomisation. All electronic and paper records containing patient data generated by the EnGraft Study are encoded with the appropriate pseudonym. Patient names are not used to report or record trial data.EnGraft data are collected in a study-specific database, using a web-based platform for remote electronic data capture. Investigators and/or their designees enter data via the online platform into an electronic case report form (eCRF) designed by the sponsor and constructed/maintained by Excelya Germany GmbH. Access to the eCRF database is password protected, and electronic login credentials are issued and controlled by the sponsor. The sponsor requires the PI to permit the sponsor, designated trial monitors and, when necessary, representatives of the regulatory authorities to inspect and/or copy medical records relevant to the study and trial documents bearing patient names.