Updates are available Correction dated 2026-01-19

Article History

Received: 30 July 2025

Accepted: 29 August 2025

First Online: 16 September 2025

Change Date: 23 November 2025

Change Type: Update

Change Details: The original online version of this article was revised due to update in Figure captions.

Change Date: 19 January 2026

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://doi.org/10.1007/s12325-025-03443-w

Declarations

:

: The authors (Ingmar Bergs, Stephan Budweiser, Hans-Heinrich Henneicke-von Zepelin, Hagen Kelm, Tom Bollmann, Johannes-Josef Tebbe, Stephan Sorichter, Stefan Lüth, Stephan Walterspacher, Henning Wege, Oliver Wiedow, Michael Dreher) received adequate remuneration for their work in this clinical trial without resulting in conflict of interest in the study results and their interpretation. Hans-Heinrich Henneicke-von Zepelin and Oliver Wiedow are employees of the sponsor of this clinical trial.

: The study was conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects adopted by the General Assembly of the World Medical Association [ ]. The planning and conduct of this clinical trial followed the national laws of Germany, the principles and guidelines for good clinical practice (GCP) laid down in Directives 2001/20/EC [ ] and 2005/28/EC [ ] of the European Parliament and the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice [ ]. The trial protocol and other study-relevant documents were submitted for review and approved by the Ethics Commission at the RWTH Aachen Faculty of Medicine in Aachen, Germany (EK 197/22, September 2022). The protocol was also reviewed and approved by the national competent authority in Germany (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), finally in February 2023 (trial registration: EudraCT 2022–000714-33, DRKS00031463) [ , ].