Ethics approval and consent to participate
All activities within this trial comply with the Declaration of Helsinki and the principles of Good Clinical Practice (GCP). This protocol was approved by the responsible ethics board:Ethics Committee of the Medical Faculty, University of Wuerzburg, ref. 215/21-sc, Jan 18, 2022.Informed consent will be obtained by trained investigators at the respective study sites. The necessary information material and consent forms will be provided by the sponsor of the trial. Patients who are not capable of giving consent and those under legal custody are excluded from participation in the study.