Research ethics approval, consent, and confidentiality
COMIRB serves as the institutional review board (IRB) of record and approved this trial on December 17, 2017. Participants will be enrolled in this trial after obtaining verbal consent. We requested, and have obtained, a waiver of documentation of written consent based on 45 CFR 46.117. We obtained a waiver of HIPAA authorization for participants in this study. Data collected as part of this project poses no more than a minimal risk of harm to privacy.