Kijak, Gustavo H.
Ahani, Bahar
Arbetter, Douglas
Chuecos, Fernando
Gopalakrishnan, Vancheswaran
Beloor, Jagadish
Brady, Tyler
Nguyen, Amy
Roe, Tiffany L.
Schuko, Nicolette
Zhang, Tianhui
Hobbs, F. D. Richard
Padilla, Francisco
Kelly, Elizabeth J.
Montgomery, Hugh
Streicher, Katie
Funding for this research was provided by:
AstraZeneca
Article History
Received: 21 August 2023
Accepted: 25 September 2023
First Online: 2 November 2023
Declarations
:
: Gustavo H. Kijak, Bahar Ahani, Douglas Arbetter, Jagadish Beloor, Tyler Brady, Amy Nguyen, and Katie Streicher are employees of AstraZeneca and owns stocks/shares. Vancheswaran Gopalakrishnan is an employee of AstraZeneca and owns stocks/shares, and is co-inventor on US patent PCT/US17/53,717 and on a provisional US patent WO2020106983A1. Fernando Chuecos, Tiffany L. Roe and Nicolette Schuko are employees of AstraZeneca. Tianhui Zhang was an employee of AstraZeneca and owns stocks/shares, and is currently employed at Eli Lilly and Company (Indianapolis, Indiana, USA). F. D. Richard Hobbs acknowledges part support as Director of the NIHR Applied Research Collaboration (ARC) Oxford Thames Valley, and Theme Lead of the NIHR OUH BRC, and has also received occasional fees or expenses for speaking or consultancy from AstraZeneca, Boehringer Ingelheim, Bayer, Bristol Myers Squibb/Pfizer, and Novartis. Francisco Padilla has received fees for conferences and research from Amgen, AstraZeneca, Ferrer, Lilly, Novartis, Servier, and Silanes. Elizabeth J. Kelly was an employee of AstraZeneca and owns stocks/shares, and is now employed at Sanofi (Swiftwater, PA, USA). Hugh Montgomery has received fees for consulting and advisory committees from AstraZeneca.
: The study was conducted in accordance with the Good Clinical Practice guidelines and the Declaration of Helsinki, Council for International Organizations of Medical Sciences International Ethical guidelines, applicable International Conference on Harmonization Good Clinical Practice guidelines, and all applicable laws and regulations. The protocol, protocol amendments, and all other relevant documentation were reviewed and approved by an institutional review board or ethics committee (see Supplementary Material Table S1 for ethics approval committee information) and are available with the previous report [CitationRef removed]. An independent Data Safety Management Board provided oversight throughout the study to ensure the safe and ethical conduct of the study. All participants provided written informed consent.