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Article History

Accepted: 22 April 2024

First Online: 9 May 2024

Declarations

:

: The COVID-PR receives funding from Gilead Sciences, GSK/Vir Biotechnology, Inc., MSD, and Roche. This study (216978) was funded by GSK and Vir Biotechnology, Inc. The open access fee for this paper was funded by GSK and Vir Biotechnology, Inc.

: Diego F. Wyszynski, Cheryl Renz, and Dragutin Rafailovic are employees of Pregistry, a company contracted by GSK and others (see the Funding statement above) to conduct the COVID-PR. Lydia Demetriou, Shirin Aliabadi, Myriam Drysdale, and Keele E. Wurst are employees of GSK and hold shares in the company. Lee P. Shulman has no conflicts of interest to declare.

: The study protocol has been approved in the United States by the WCG IRB (20214420), in Japan by the Medical Corporation TOUKEIKAI Kitamachi Clinic ERB (RVG0947720230315), and in Australia by the Bellberry Human Research Ethics Committee (2022-04-403). Clearance that approval is not required to conduct the study has been given by Ethics Committees in the following countries: Bulgaria, Canada, Croatia, Czech Republic, Denmark, Germany, Greece, Hong Kong, Italy, Malaysia, New Zealand, Poland, Romania, Singapore, South Africa, South Korea, and the United Kingdom. The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

: Eligible subjects signed an electronic consent form prior to enrolling in this study.

: Participants provided informed written consent before taking part in the study.

: This manuscript has no associated data or the data will not be deposited. The COVID-PR study protocol may be made available by the corresponding author on reasonable request, following applicable regulations.

: Not applicable.

: The original study protocol was designed by Diego F. Wyszynski, who planned the study, designed the study methodology, supervised data collection and data verification, and drafted the first version of the article. Lydia Demetriou, Cheryl Renz, Shirin Aliabadi, Dragutin Rafailovic, Lee P. Shulman, Myriam Drysdale, and Keele E. Wurst provided advice on the study methodology and edited the first and final versions of the article. All authors have read and approved the final version of the manuscript.