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Article History

Received: 19 January 2025

Accepted: 27 October 2025

First Online: 1 December 2025

Declarations

:

: The trial will be conducted in accordance with the “ethical principles for medical research involving human subjects” established by the 18th World Medical Association General Assembly in Helsinki (1964), including all subsequent amendments. The procedures outlined in this study protocol for conducting, evaluating, and documenting the trial are designed to ensure compliance with the ethical principles specified in the current version of the Declaration of Helsinki. Therefore, all necessary measures have been implemented to ensure patient welfare. Before enrollment in the study, subjects will be informed about the intention, intervention, assessments, and potential consequences of the study. An informed consent document, containing details about the study, will be provided to each participant. After reviewing the informed consent document, subjects must provide written informed consent to participate in the study. The original consent form will be retained by the investigator. This study was approved by the Ethics Committee of the Medical Faculty, University of Heidelberg, Germany (reference number S-729/2024; approval date 20 December 2024). Local ethics approval will be obtained from each participating center prior to the start of patient recruitment.

: All authors consented to the study protocol to be published in its current version.

: There are no conflicts of interest associated with this study. All investigators and involved parties declare that they have no financial or personal relationships that could potentially influence the study’s outcomes.