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Article History

Received: 19 May 2025

Accepted: 18 June 2025

First Online: 13 July 2025

Declarations

:

: Kai M. Beeh has received personal and/or institutional compensation for clinical research, consulting, and/or lecturing fees from AstraZeneca, Bosch Healthcare Solutions, Chiesi, Clario, GSK, Novartis, Menarini/Berlin Chemie, Orion, Sanofi, and Sterna. Kai M. Beeh is an Editor-in-Chief of Pulmonary Therapy. Kai M. Beeh was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions.Karl Scheithe declares no conflict of interest.Heike Schmutzler is a current employee of the sponsor, Berlin Chemie.Saskia Krüger was an employee of the sponsor Berlin Chemie at the time the study was conducted and evaluated.

: The ELLITHE study was registered under the German Clinical Trials Register (identifier: DRKS00031897) The study was carried out in accordance with Good Clinical Practice guidelines under the provisions of the latest version of the Declaration of Helsinki (2013) and received approval from of the State Chamber of Physicians of Hesse (“Ethikkommission der Landesärztekammer Hessen”) as the coordinating ethics committee of the national chief investigator. The study was registered at the German Clinical Trials Register (DRKS00031897). All patients provided signed informed consent.

: The authors would like to thank all study sites and patients involved in the ELLITHE study.