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Article History

Received: 21 January 2025

Accepted: 26 February 2025

First Online: 18 March 2025

Declarations

:

: Fenling Fan has served as a scientific committee member for Johnson & Johnson. Stacy Davis, Michael Friberg, Jörg Linder, and Alvaro Agustin Rodriguez are employees of Johnson & Johnson. Michael Friberg is an employee of Janssen-Cilag Limited and owns shares of stock/stock options in Johnson & Johnson. Jason Randall, Claire Burbridge, Jennifer Rafalski, and Melanie Hughes have no financial interests to declare. Jason Randall, Claire Burbridge, and Melanie Hughes are employees of Clinical Outcomes Solutions. Jennifer Rafalski was an employee of Clinical Outcomes Solutions at the time that this research was conducted. Jörg Linder is an employee of Janssen-Cilag GmbH and own shares of stock/stock options in Johnson & Johnson. Kelly Chin has served as a scientific committee member for Johnson & Johnson; has received research grants/support from Johnson & Johnson, Altavant, United Therapeutics, Pfizer, Merck, and Gossamer Bio; has received support for travel to meetings from Johnson & Johnson; and has received consultancy fees from Johnson & Johnson, Altavant, United Therapeutics, Gossamer Bio, and Merck. Ekkehard Grünig received research grants to his institution from Acceleron, Actelion, Aerovate, Ferrer, Gossamer, Insmed, Janssen, Keros, Liquidia, Merck, MSD, Novartis, OMT, United Therapeutics; consultancy fees from Actelion, Ferrer, Janssen, Merck, MSD; speaker honoraria from Actelion, Ferrer, Janssen, Merck, MSD; participation on advisory board for Actelion, Ferrer, MSD. Pavel Jansa received consulting fees and grants from Janssen Pharmaceutical Companies of Johnson & Johnson, AOP Orphan Pharmaceuticals, and MSD; participates in a Data Safety Monitoring Board or Advisory Board for Janssen Pharmaceutical Companies of Johnson & Johnson and AOP Orphan Pharmaceuticals.

: This study was conducted in compliance with Good Clinical Practice, including the International Conference on Harmonization Guidelines, and consistent with the Declaration of Helsinki 1964 and its later amendments. In addition, the study followed all applicable local laws and regulatory requirements relevant to the conduct of qualitative research. Ethical approval for this sub-study was obtained by clinical study sites in each country; the trial protocol was updated to include the interviews sub-study and ethical approval was granted for this protocol amendment (Supplementary Table S3). All patients were required to sign and date the interviews sub-study informed consent form (ICF) before taking part in the interview. This ICF included a Declaration of Helsinki specific to each country. Patients also provided verbal confirmation of consent at the time of the interview. The clinician’s verbal consent was collected during the interview. Participants provided informed consent for their quotes to be used when reporting results. The ICF stated that quotes from the interviews will be used while reporting results and will be associated with the participants unique identification number that they were assigned in the A DUE main study. In addition, patients provided verbal confirmation of consent at the time of the interview. The clinician’s verbal consent was collected during the interview. Participants provided informed consent for their quotes to be used when reporting results.