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Article History

Received: 1 January 2026

Accepted: 17 February 2026

First Online: 9 March 2026

Declarations

:

: All procedures involving human participants were conducted in accordance with the ethical standards of the local institutional review board (EA4/100/23), national regulations, and the Declaration of Helsinki and its later amendments. Only patients capable of providing informed consent were included.

: Included within the ethics approval granted by the local institutional review board (EA4/100/23).

: The authors declare no competing interests.

: The full trial protocol is available at the German Clinical Trials Register (DRKS00034040), . Date of registration: 2024-04-15. The original study protocol, finalized before recruitment commenced, is provided as a supplementary file. All study planning, predefined endpoints, and statistical analyses were finalized prior to patient enrolment and conducted strictly according to the approved protocol.