Shah, Manasee V.
Solem, Caitlyn T.
Bell, Kelly F.
Aziez, Amine
Sun, Xuezheng
Du, Mandy
Du, Ella X.
Yang, Hongbo
Wang, Hongjue
Hua, Qi
Tapan, Umit https://orcid.org/0000-0002-3906-3004
Funding for this research was provided by:
GSK
Article History
Received: 26 November 2024
Accepted: 11 March 2025
First Online: 15 April 2025
Declarations
:
: Caitlyn Solem, Amine Aziez, and Kelly F. Bell are employees of and have stock and other ownership interests in GSK. Xuezheng Sun and Manasee V. Shah were employees of GSK at the time of the study’s conduct; Xuezheng Sun is a current employee of Chiesi USA. Mandy Du, Ella X. Du, Hongbo Yang, Hongjue Wang, and Qi Hua are employees of Analysis Group, Inc., which received consulting fees from GSK for this study. Umit Tapan has received an educational grant from Pfizer and is an advisory board member for Sanofi/Genzyme/Regeneron and Pfizer, a speaker for AstraZeneca-sponsored symposium and TD Cowen, and a consultant for GSK.
: Because no identifiable patient information was collected, obtaining patient consent was not required. All data used in this study were fully anonymized and actual dates were systematically shifted by a random number to further protect patient privacy. Given these safeguards, the study met the criteria for exemption from full institutional review board (IRB) review as determined by Pearl IRB (Indianapolis, IN, USA) on August 31, 2022. The study was conducted in accordance with the protocol, applicable regulations, and guidelines governing clinical study conduct and the ethical principles that have their origin in the Declaration of Helsinki.