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Article History

Received: 23 July 2025

Accepted: 29 November 2025

First Online: 11 December 2025

Change Date: 7 June 2026

Change Type: Update

Change Details: The Statistical analisys plan was added as supplementary material.

Declarations

:

: Ethics approval for this study was obtained from the Ethics Committee of Technische Universität Dresden, Dresden, Germany, in accordance with national regulations and the Declaration of Helsinki (Approval Number: BO-EK-68022024). Additionally, approval was granted by the respective ethics committees of all participating hospitals. Any substantial changes to the protocol will be submitted to the responsible ethics committees for approval prior to implementation. The coordinating center will notify all participating sites of approved amendments and distribute updated protocol versions to the local principal investigators for inclusion in the Investigator Site File. Any deviations from the approved protocol will be fully documented and reviewed using a standardized breach report form. The clinical trial registry entry (ClinicalTrials.gov) will be updated accordingly. As the General Data Protection Regulation (GDPR) does not apply to the data of deceased individuals, as stated in Recital 27, consent to participate is not required for this study. The trial is registered at ClinicalTrials.gov, including all items from the WHO Trial Registration Data Set ( ). Protocol version is 3.0, dated August 08, 2024.

: Not applicable. Trial results will be published in a peer-reviewed scientific journal. Authorship will be based on scientific contributions to study design, conduct, analysis, or manuscript preparation.

: The authors declare that they have no competing interests.