Ethics approval and consent to participate {24}
MAY, RECRUITMENT
According to § 15 of the Professional Code for Physicians in Germany (Berufsordnung für die in Deutschland tätigen Ärztinnen und Ärzte), the coordinating investigator has consulted the Ethics Committee (EC) of the University of Ulm before the start of the trial. Approval was granted on 23 May 2022 (Number 76/22). Also, all other participating sites will or have already consulted their responsible ethics committees, before recruitment is started at the respective site. Any changes have to be documented in a written amendment. They will be restricted to exceptional cases. Amendments then become part of the clinical trial protocol. The EC will be informed of all subsequent protocol amendments in order to determine whether formal approval must be sought and whether the informed consent document should also be revised. The EC will be informed of the end of the trial by the coordinating investigator.