Youssef, Amir S. http://orcid.org/0000-0003-4413-066X
Ismail, Mohamed
Han, Kelong
Magee, Mindy
Nader, Ahmed
Funding for this research was provided by:
GSK (GSK Study ID 218363)
Article History
Received: 19 December 2023
Accepted: 12 April 2024
First Online: 25 May 2024
Declarations
:
: Ahmed Nader, Amir S Youssef, Kelong Han, and Mindy Magee are employees of GSK and hold stocks/shares in GSK. Mohamed Ismail is an employee of Enhanced Pharmacodynamics LLC and clinical pharmacology and pharmacometrics consultants supporting EOP2 analysis.
: Ethical approval was obtained for each study. The studies were conducted in accordance with the International Council on Harmonization Guideline for Good Clinical Practice and the Declaration of Helsinki. The study protocols, any amendments, informed consent, and other information that required pre-approval were reviewed and approved by a national, regional, or investigational center ethics committee or institutional review board, in accordance with the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice and applicable country-specific requirements, including US 21 Code of Federal Regulations (CFR) 312.3(b) for constitution of independent ethics committees. Each study obtained written informed consent from each participant prior to any study-specific procedures.