von Maltzahn, Robyn
Mayo, Marlyn J.
Smith, Helen T.
Thompson, April
Das, Sugato
de Souza, Andrea Ribeiro
Lisi, Edoardo
Levy, Cynthia
McLaughlin, Megan M.
Jones, David
Funding for this research was provided by:
GSK (201000)
Article History
Received: 7 July 2023
Accepted: 2 April 2024
First Online: 12 June 2024
Declarations
:
: The study was performed in accordance with the Declaration of Helsinki, International Conference on Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice, and applicable country-specific requirements. The study protocol, 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. Written informed consent was obtained from all patients before participation.
: Not applicable.
: clinicaltrials.gov, NCT02966834. Registered 15 November 2016.
: RVM is an employee of GSK and holds GSK shares. MJM has received research support from CymaBay, GSK, Intercept, Mallinckrodt, Salix, and TARGET RWE; and has consulted for CymaBay, GSK, Mallinckrodt, Mirum, and TARGET RWE. HTS is an employee of GSK and holds GSK shares. AT was an employee of GSK at the time of the study and holds GSK shares. SD is an employee of GSK. ARdS is an employee of GSK and holds GSK shares. EL is an employee of GSK and holds GSK shares. CL is an ABIM committee member and an associate editor of <i>Hepatology</i>; has consulted for Calliditas, CymaBay, DISC Medicine, Gilead, GSK, Intercept, Mirum, Pliant, Target RWE, and Ipsen; has participated on advisory boards for Bausch, Cymabay, GSK, Ipsen, Intercept and Pliant; and has received research grants from Cara Therapeutics, CymaBay, Disc Medicine, Escient, Genfit, Calliditas, Gilead, GSK, HighTide, Intercept, Mirum, Pliant, Target RWE, Ipsen and Zydus. MMM is an employee of GSK and holds GSK shares. DJ has received grant funding or fees from Abbott, Falk, GSK, Intercept, Novartis, and Pfizer.