Document is current

Article History

Received: 4 March 2025

Accepted: 31 July 2025

First Online: 22 August 2025

Declarations

:

: All studies were conducted in accordance with the Declaration of Helsinki and approved by the following ethics committees: Commissie voor Medische Ethiek, Universitair Ziekenhuis Gent, Belgium; CPP Sud Mediterranee V, CHU de NICE - Hopital de CIMIEZ, France; Ethikkommission des Fachbereichs Medizin der Johann Wolfgang Goethe-Universität Frankfurt am Main, Germany; Comitato Etico, Istituto Nazionale per le Malattie Infettive “Lazzaro Spallanzani” IRCCS, Italy; Comitato Etico, IRCCS Ospedale S. Raffaele di Milano, Italy; Comitato Etico della Provincia di Bergamo, ASST Papa Giovanni XXIII, Italy; CEIC Hospital Universitari de Bellvitge, Spain; National Research Ethics Service Committee London - Hampstead Research Ethics Committee, United Kingdom; Sunnybrook Research Ethics Board, Sunnybrook Health Sciences Centre, Canada; Ottawa Health Science Network Research Ethics Board, Canada; Centre for Applied Ethics/MUHC Research Ethics Board, McGill University Health Centre, Canada; Advarra Institutional Review Board, United States; Prisma Health Institutional Review Board, United States; Institutional Review Board at Dallas, University of Texas Southwestern Medical Center, United States; Duke University Health System Institutional Review Board, United States; Bellberry Human Research Ethics Committee, Australia; St Vincent’s Hospital Human Research Ethics Committee, Australia. Institutional review boards at each site granted ethical approval, and all participants provided written informed consent.

: Not applicable.

: CMK reports grants or contracts from Janssen. SKG reports grants or contracts from the National Institutes of Health and ViiV Healthcare; consulting fees from Gilead Sciences, Inc., and ViiV Healthcare. PNK reports grants or contracts from ViiV Healthcare, Gilead Science, Inc., Merck, and Theratechnologies; consulting fees from ViiV Healthcare, Gilead Sciences, Inc., and Merck; participation on a data safety monitoring board or advisory board from ViiV Healthcare, Gilead Sciences, Inc., and Merck; stock or stock options from Merck, Pfizer, Gilead Sciences, Inc., Johnson & Johnson, GSK, and Moderna. ARW, BG-P, HL, and JTH are employees and stockholders of Gilead Sciences, Inc. JKR reports grants or contracts from Gilead Sciences Inc.; consulting fees from AbbVie and Boehringer Ingelheim; payment or honoraria from Gilead Sciences Inc., Janssen, MSD, and ViiV Healthcare; participation on a data safety monitoring board or advisory board from Berlin Cures; other leadership or fiduciary role for EuroTESt.