Document is current

Article History

Received: 17 October 2022

Accepted: 26 July 2023

First Online: 13 September 2023

Declarations

:

: The COMET-ICE study was conducted in accordance with the principles of the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Council for Harmonisation Good Clinical Practice guidelines, and applicable laws and regulations. Written informed consent was provided by all patients prior to study entry.

: Not applicable.

: PG, TJHK, HJB, DB, and AL are employees of, and/or hold stocks/shares in, GSK. SS, MA, and EA are employees of, and/or hold stocks/shares in, Vir Biotechnology, Inc. CMR was an employee of Vir Biotechnology, Inc. at the time of study. JHP III has consulted for Arrevus, Eicos, Eli Lilly, Evofem, Eyecheck, Fuji, Gilead, Johnson & Johnson, Microbion, OPKO, Otsuka, Resolve, Romark, Shinogi, SpineBioPharma, and UTIlity, outside the submitted work, and for GSK and Vir Biotechnology, Inc. for the submitted work. AG and AES have acted as trial investigators for Vir Biotechnology, Inc. and received non-financial support from Vir Biotechnology, Inc. during the conduct of the study. EHS has acted as a trial investigator for Vir Biotechnology, Inc. and received non-financial support from Vir Biotechnology, Inc. during the conduct of the study; has received research support from AbbVie, Eisai, Eli Lilly, GSK, Ironshore, Otsuka, and Vir Biotechnology, Inc.; and served on speaker bureaus for AbbVie, Janssen, and Teva.