Materials and methods
ADVERSE EVENTS
Possible risks and benefits of study participation were discussed with, and signed informed consent was obtained from, all participants after a full description of study procedures and prior to conducting any study procedures. The study was approved by the University of Arizona Institutional Review Board (IRB), was considered exempt by the IRB of the University of Colorado Boulder and was registered on ClinicalTrials.gov as NCT01625546. Details of the study design, primary behavioral outcomes, and occurrence of adverse events have been previously reported [