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Article History

Received: 29 March 2024

Accepted: 14 February 2025

First Online: 2 June 2025

Declarations

:

: The study protocol was approved by the Ethics Committee of the German State of Baden-Württemberg Chamber of Physicians and Surgeons (F 2021-157). The study has been registered with the German National Registry of Clinical Studies (DRKS00028026). The first patient was enrolled July, 8, 2023. The last patient out is expected for May 15, 2025.The study may provide individual benefit for patients in both groups. Risk of AR realization is very low. After investigation and oral clarification by a doctor, patients sign the written declaration of informed consent. In addition, they receive written patient information including a description of the study and its purpose, possible AEs, name and address of the insurer, and explicit data protection information. Access to personal data is restricted to clinical investigators (physician and monitors) and patients. With the exception of the monitors authorized by the patients´ informed consent, data access by the sponsor is restricted to anonymous results. Statistics will be calculated on the basis of pseudonymized data. The study will be conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki and in compliance with Good Clinical Practices (GCP), including the archiving of essential documents. Protocol modifications will be communicated to relevant parties (IRB, investigators, …) in advance and in accordance with local regulatory requirements.

: The above mentioned informed consent includes the consent to publish anonymous data. The participant information materials and informed consent form are available from the corresponding authors on request.

: The authors declare that they have no competing interests.