Ethical considerations and trial registration
ICH
The protocol V03F from 09.08.2021 was developed and approved by the sponsor. The study will be performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the ICH Good Clinical Practice guidelines. The local Ethics Committee of the University of Dusseldorf and the local ethic committees of the participating centers throughout Germany approved the study.Any change in the study protocol and/or informed consent form will be presented to the named Ethics Committee. They have to be approved by the Ethics Committee before implementation (except for changes in logistics and administration or when necessary to eliminate immediate hazards). The sponsor, the competent authorities and the ethics committee may stop the clinical trial or participation of a clinical trial site in the clinical trial for medical, safety, regulatory, administrative or other reasons consistent with ICH-GCP, the respective European Union’s and national legislation. The study is registered at the ‘European Union Drug Regulating Authorities Clinical Trials’ (EudraCT 2018–002936-26) and clinicalstrials.gov (NCT04059562).