Ethics Statement
The study was reviewed by the Institutional Review Board (IRB) at the University of Texas at Austin and a determination was made that the research did not meet the criteria for human subjects research as defined in the Common Rule (45 CFR 46) or FDA Regulations (21 CFR 56). Each provider ensured compliance with their own internal ethics and governance systems. The principles of the STROBE statement, and the MARE supplement, were followed.(14)