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Authors
Arnold, Matthias
Gscheidle, Sonja
Lange, Saskia
Haring, Malte
Stegmeier, Elmar
Klampfleitner, Helena
Kurscheid, Clarissa
Schluttig, Marie
Borchers, Uwe
Stampa, Susanne
Schnecke, Jan Hendrik
von Schell, Andreas
Pries, Rebecca
Miethe, Johannes
Galle, Georg
Brinkmeier, Michael
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Funding
Funding for this research was provided by:
Joint Federal Committee of the Federal Republic of Germany (01NVF22116)
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Article History
Received: 17 November 2025
Accepted: 1 June 2026
First Online: 11 June 2026
Declarations
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: The work described has been carried out in accordance with the Declaration of Helsinki. All participants provided written informed consent. The study was approved by the Ethics Committee of the Medical Association of Ostwestfalen-Lippe (Reference Number: 2024-057-f-S). Any protocol amendments will be submitted to and approved by the sponsor prior to implementation. The principal investigator will subsequently inform all participating centers. Protocol deviations will be documented using a breach report form, and all amendments will be updated in the DRKS trial registry.
: Not applicable.
: The authors declare no competing interests.
