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Article History

Received: 6 November 2025

Accepted: 20 April 2026

First Online: 25 April 2026

Declarations

:

: Ethical approval for the PRIMA trial has been obtained from the Ethics Committee of the Medical Faculty of Heinrich-Heine University Düsseldorf, Germany (reference number: 2021–1389). Local ethical approvals have been granted or will be confirmed at all participating study sites prior to patient recruitment.The trial will be conducted in accordance with the Declaration of Helsinki (2013), Good Clinical Practice (ICH-GCP), and all applicable national and European data protection regulations (including GDPR). Written, informed consent to participate will be obtained from all participants prior to any study-related procedures. Participants are informed about study objectives, procedures, risks, benefits, data protection, and their right to withdraw consent at any time without disadvantage.

: Not applicable. No identifying images or other personal or clinical details of individual participants are included in this manuscript or will be included in reports arising from the trial. Participant information and informed consent materials can be obtained from the corresponding author upon reasonable request.

: The authors declare no competing interests.