Received: 24 March 2020
Accepted: 30 December 2020
First Online: 25 January 2021
Change Date: 12 April 2021
Change Type: Update
Change Details: The Funding note has been updated.
Ethics approval and consent to participate
: This trial is conducted in accordance with the Medical Association’s professional code (Berufsordnung der Bundesärztekammer) §15. Investigators will adhere to the ethical principles laid out in the Declaration of Helsinki and ICH-GCP E6. The trial protocol has been formulated in accordance with the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) and SPIRIT guidelines (the SPIRIT checklist is provided as Supporting file InternalRef removed). Prior to trial enrolment, written informed consent will be obtained from all trial participants. This trial protocol (version 3.0, dated September 2, 2020) has been approved by the independent ethics committee (IEC) of the medical faculty at Heidelberg University. Secondary approval of the corresponding ethical bodies of all other participating centers has been or will be obtained.
: Not applicable.
: The authors declare that they have no competing interests.