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Article History

Received: 19 January 2024

Accepted: 20 November 2024

First Online: 30 January 2025

Declarations

:

: The study was approved by the ethics committee of the University of Leipzig (No. 187/21-ek). All participants or their legal guardians which we included in the registry gave their informed and voluntary consent to participate in this study. The inquiry and further investigations will be performed based on the Declaration of Helsinki.

: All participants or their legal guardians gave their informed and voluntary consent for their data to be published anonymously according to the German data protection standards and the European General Data Protection Regulation. Future participants will be informed in sufficient detail about the general conditions and the data protection concept. The data protection concept provides for the personal data to be stored on a different server than the pseudonymized health data. Only KaRhab team members can link the health data with the pseudonymized data. This means that retrospective linking of the data, e.g. to delete data when participants wish to withdraw from the registry, remains possible while still ensuring a high standard of data security.

: The authors declare not to have any Conflict of interest.