Ethics
The trial was conducted in accordance with the principles of the Declaration of Helsinki, International Council for Harmonisation Good Clinical Practice guidelines, and applicable regulatory requirements. All patients provided written informed consent before participating in the trial. The local institutional review board or ethics committee at each study center oversaw trial conduct and documentation. Ethics approval was obtained from the following ethics review boards: WCG IRB, Puyallup, WA (IRB00000533); Medicasur, Mexico City, Mexico (20CI09012015, CB9012009 & 20CI09012015); Hospital La Mision S.A. de C.V, Monterrey, Mexico (IRB00011076, COBBIOTICA-19-CEI-008-20160729 & 20CI09012015); Providence St Joseph's Health, Renton, WA (STUDY2020000419 & STUDY2020000465); Lifespan—Rhode Island Hospital, Providence, RI (CMTT/PROJ no: 213620); Research Compliance Office, Palo Alto, CA (IRB 5 Registration4593/Eprotocol: 57728); Advarra IRB, Columbia, MD (MOD009333300).