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Article History

Received: 10 January 2023

Accepted: 4 June 2023

First Online: 26 June 2023

Declarations

:

: NCT04556591: All study procedures were conducted in accordance with the United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812) and research best practices. Study procedures have been approved by IRBMED (Application Approval HUM00184455 and is registered with ClinicalTrials.gov (NCT04556591). NCT04570930: All study procedures are being conducted in accordance with the United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812) and research best practices. The protocol, informed consent document, and all participant materials have received approval from IRBMED (9/18/2020), which is serving as the institutional review board (IRB) of record for both data collection sites (IRBMED Multi-site Application Approval HUM00181282; IRBMED University of Michigan Site Application Approval HUM00186921; IRBMED Baylor College of Medicine Site Application Approval SITE0000087; Baylor College of Medicine/Memorial Hermann IRB number H-48478. This trial is also registered with ClinicalTrials.gov (NCT04570930). Informed consent was obtained from all participants prior to their participation in either of the trials that supported the analyses provided in this manuscript.

: The authors declare no competing interests.