Gagner, Michel http://orcid.org/0000-0001-6068-0333
Abuladze, David
Koiava, Levan
Buchwald, J. N.
Van Sante, Nathalie
Krinke, Todd
Article History
Received: 20 February 2023
Revised: 23 June 2023
Accepted: 26 June 2023
First Online: 2 July 2023
Declarations
:
: The study was conducted in compliance with the registered Clinicaltrials.gov protocol (#NCT05322122) and in accord with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments, as well as with ISO14155 regulations, 21 CFR Parts 11, 50, 54, 56, and 812 Good Clinical Practices.
: Written informed consent was obtained from all individual participants included in the study.
: Michel Gagner is a consultant with stock options in GT Metabolic Solutions; a consultant for Medtronic, Inc.; and Lexington Medical, Inc., with stock options in Lexington Medical, Inc. David Abuladze is a consultant for GT Metabolic Solutions without remuneration. Levan Koiava declares no conflict of interest. Jane Buchwald is a GT consultant with GT stock options; she received grants from Ethicon, Inc.; M.I.D.; Society of Bariatric and Metabolic Surgeons of Kazakhstan; Holy Family Hospital, Israel; and the American College of Surgeons. Nathalie Van Sante was an employee of GT Metabolic Solutions, Inc., during the study and drafting of the manuscript. Todd Krinke is a GT employee with stock options.