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)