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Article History

Received: 7 January 2025

Accepted: 2 March 2026

First Online: 5 March 2026

Declarations

:

: This trial was registered with EudraCT under the number: EudraCT 2013-004653-25. The EudraCT number 2013-004653-25 has been issued for your Sponsor’s Protocol Code Number Repha_1362 on 28th of October 2013. Ethical approval was granted by the Ethics Committee of the Medical Association of Westphalia-Lippe and the Medical Faculty of the Westphalian Wilhelms University Münster, ID: 2014-088-f-A. The study was approved on 2nd of May 2014. The study protocol, patient information, and informed consent form were all authorised by the German Federal Institute for Drugs and Medical Devices and registered with the competent authority (EudraCT 2013-004653-25). Prior to the investigation, written informed consent was obtained from all patients. This clinical trial was conducted in accordance with the ethical principles of Good Clinical Practice (GCP), which has its origins in the Declaration of Helsinki, and in strict compliance with the German Medicines Act (AMG), the GCP Regulation (GCP V) and the German Federal Data Protection Act (BDSG). This ensures that the rights, safety and well-being of patients are protected and that the results of the clinical trial are credible.

: Not applicable.

: Repha GmbH commissioned Mediconomics GmbH as a full service CRO with planning, conduct, analysis and reporting of this clinical trial regarding an authorised medicinal product. This manuscript reports the results of the clinical trial and is intended to publish up to date medical evidence.This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Repha GmbH acted as the financial sponsor for this clinical trial. The trial was designed, developed and prepared for publication by Mediconomics GmbH on behalf of Repha GmbH.