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Article History

Received: 4 March 2024

Accepted: 5 August 2025

First Online: 2 September 2025

Declarations

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: The research project will be carried out in accordance with the Helsinki Declaration, the Danish Data Protection Act, the Danish Health Act, and the General Data Protection Regulation (EU) 2016/679 (GDPR).The study is approved through the CTIS and will be conducted in compliance with the Clinical Trials Regulation (EU) No 536/2014 (CTR) and with the principles of good clinical practice, as this statement is a requirement under the CTR.The study will be registered in the US Clinical Trials database ( ), which is based on guidelines defined by the Food and Drug Administration.Since study participants will not be exposed to irresponsible risks and can greatly benefit from the study’s results and participation in the study, we believe that the study is scientifically and ethically sound.Participation in the trial is voluntary, and participants will not receive any form of financial compensation for participation. Participants are protected under the Personal Data Processing Act, and the study is reported to the Regional Science Ethics Committee (VEK), the Danish Medicines Agency (Lægemiddelstyrelsen), and the Danish Data Protection Agency (Videnscenter for Dataanmeldelser).The trial is covered by the patient compensation scheme. Participants can apply for compensation in accordance with Statutory Order No. 1113 of 7 November 2011 on the right of appeal and compensation in the healthcare system if participants experience unexpected damage during the trial or at inclusion.

: Not applicable.

: Outside the submitted work: CSU has received grants from Sanofi, Boehringer Ingelheim, AstraZeneca, and Novartis; speaker fees from Orion Pharma, AstraZeneca, and TEVA; and consulting fees from Chiesi, Orion Pharma, AstraZeneca, GSK, and TEVA and has been on advisory boards for Novartis, Sanofi, GlaxoSmith Kline, Chiesi, AstraZeneca, and Boehringer Ingelheim. EB reports a grant from Boehringer Ingelheim; fees for presentations from BI and Chiesi; support for travel from Boehringer Ingelheim and Roche; has participated on Data Safety Monitoring Boards or advisory boards for AbbVie and Boehringer Ingelheim. JV has received consulting fees from AstraZeneca for serving on a trial steering committee, and has received payment or honoraria for presenting at meetings from ALK-Abello, AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, and Teva.