Document is current

Article History

Received: 24 October 2025

Accepted: 3 March 2026

First Online: 14 April 2026

Declarations

:

: This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with the International Council for Harmonisation (ICH)/Good clinical practice (GCP) guidelines, applicable regulatory requirements and the AstraZeneca policy on Bioethics. All patients provided written informed consent. The study protocol, the participant information and consent form, and other relevant study documentation were approved by the independent ethics committee/institutional review boards from each participating country (Supplemental Table S6).

: Not applicable.

: Tania Hugo, Andrew R Harper, Jacob Leander, Pål Lundin, David Bock, Xiao-Hong Zhou, David R Close and Hitesh Pandya are employees of AstraZeneca and may own stock or stock options. Steve Burns, Philip Gardiner, Robert Palmér, David J Keeling and Maria G Belvisi are former employees of AstraZeneca and may own stock or stock options. Irina Bondarenko is an employee of Parexel Int. Erol Wiegert and Mary F Fitzgerald were consultants for Pieris Pharmaceuticals at the time study was conducted and may own stock or stock options. Paul M O’Byrne has received grants and consultancy fees from AstraZeneca, GSK, MedImmune and Novartis; consultancy fees from Covis Pharma and Teva Pharmaceuticals; speaker fees from AstraZeneca, Chiesi and Menarini Group; and grants from Bayer and Merck.