MATERIALS AND METHODS
The study was conducted in accordance with the U.S. Code of Federal Regulations and ethical principles of the Declaration of Helsinki, Good Clinical Practices, and the International Council for Harmonisation guidelines. The study protocol and all amendments were reviewed by an Institutional Review Board for the study center (clinicaltrials.gov: NCT04368585; Advarra, Columbia, MD). Written informed consent was obtained from each subject prior to participation in any study procedures.