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Article History

Received: 19 August 2020

Accepted: 25 November 2020

First Online: 8 January 2021

Ethics approval and consent to participate

: The EUROPA trial is conducted according to §15 of the German Medical Association’s professional code (<i>Berufsordnung der Bundesärztekammer</i>). To ensure patients’ rights and safety, the responsible investigator will ensure that the trial is conducted according to the ethical principles laid out in the Declaration of Helsinki []. Written informed consent will be obtained from all study participants before they are included in the EUROPA trial. This protocol is designed to ensure that the trial will be conducted and analysed in accordance with ICH-GCP E6 []. The protocol has already been approved by the independent ethics committee of the Medical Faculty of the University of Heidelberg. The trial protocol has been formulated in accordance with the recommendations of the CONSORT and SPIRIT guidelines [, ]. The independent ethics committee will be informed of all subsequent protocol amendments in order to determine whether formal approval needs to be sought and whether the informed consent document should also be revised.

: Not applicable

: The authors declare that they have no competing interests.