2.1. Ethics
MAY
The application for ethical approval including study protocol and informed consent form was reviewed by the Independent Ethics Committee of the Medical Association of Schleswig-Holstein on 30 May 2021. Ethical evaluation resulted in written stated favourable opinion, with reference number 063/21 (I), on 1 July 2021.The study was conducted in line with the principles of the Declaration of Helsinki, in accordance with the guidelines for Good Clinical Practice (ICH-GCP) and in accordance with the study protocol (Study protocol_Slim-LfX-2020, version 1.0_17.03.2020; see 