Ethics approval and consent to participate
EVENT
This study received a favourable opinion from the Ethics Committee of the University of Regensburg, Germany. The vote was given under the reference number 20–1842-112. Changes to the trial protocol are only possible via official protocol amendments that are enacted by the trial sponsor. In the event that the protocol is amended, a new signed version of the protocol will be released (with updated version number and date) and circulated to all study staff.