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Article History

Received: 11 July 2025

Accepted: 3 April 2026

First Online: 16 April 2026

Declarations

:

: The ethics committee of Charité – Universitätsmedizin Berlin granted full approval to the “StäB 36 PSR MK” trial on November 28, 2024 (EA2/203/24). The ethics boards of all study sites followed this approval. The trial followed current recommendations for implementation science and naturalistic study reporting standards. The trial was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines, and the provisions of Good Epidemiological Practice. The study also complied with the German Federal Data Protection Act, Social Security Law Book, and the General Data Protection Regulation. All participant-related data were collected, stored, and published in anonymized form to ensure privacy. The data protection officer at Charité – Universitätsmedizin Berlin granted full approval for the data assurance concept of the trial. The data protection officers at all study sites followed this approval. Due to the nature of the retrospective analysis of routine control data, the Study Information and Consent form was not applicable in advance. To fulfil the informational requirement, even in a retrospective study (without obtaining consent), patients of the study sites will be informed about the analysis of clinical routine data for research purposes via a notice in the clinic or on the project’s website.

: Not applicable.

: The authors declare no competing interests.