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Article History

Received: 5 January 2026

Accepted: 19 March 2026

First Online: 25 March 2026

Declarations

:

: Before the start of the study, the study protocol, the informed consent document(s), and any other documents to be handed out to study participants were submitted to the independent Ethics Committee of the Medical Faculty, Heidelberg University. A written favorable vote with the study sign S-169/2024 was obtained on October 8th, 2024. This protocol publication is based on the 9th amendment of the study protocol as of March 20th, 2026. All protocol amendments are being communicated to the recruiting centers via an email list and in biweekly online meetings. Moreover, positive votes have been obtained so far from the responsible local ethics committees of 8 of the 10 recruiting clinics (see Table S1, Supplemental Material).The study will be conducted in adherence with the “Ethical principles for medical research involving human subjects” of the 18th World Medical Association General Assembly in Helsinki (1964) in their current version.Before being admitted to the study, the patient must consent to participate after having been fully informed in writing and orally by a physician about the nature and scope of the planned investigation, in particular the importance, risks, possible benefits, and individual consequences of the study and their right to terminate the participation at any time.Consent will be confirmed by the personally dated signature of the patient on the declaration of consent form and by the personally dated signature of the physician conducting the informed consent discussion.

: Not applicable.

: The authors declare no competing interests.