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Article History

Received: 5 November 2023

Accepted: 28 February 2024

First Online: 11 March 2024

Declarations

:

: The study protocol (version 1.1, 10 August 2023) has been approved by the ethics committee of the University Hospital Cologne. The trial was registered in the DRKS (German Clinical Trials Registry) on 08/14/2023 under the ID DRKS00031500. Written, informed consent to participate will be obtained from all participants. Patients can revoke their consent verbally or in writing at any time without giving reasons. A distinction is made here as to whether patients wish to withdraw from the intervention, the assessments, or the consent to the transfer of health insurance data. If patients only wish to withdraw from the intervention and the assessments, the health insurance data used to determine the primary outcome can still be collected.

: As part of the consent form, it is made clear that all data collected as part of the trial will only be published in a pseudonymized or anonymized form. In this context, participants also indicate that they agree to pseudonymized data being published. Data that would allow the identification of individual participants due to their level of detail will not be published.

: The authors declare that they have no competing interests.