Institutional approval
The protocol was approved by the Institutional Review Board of the
University of Pittsburgh (STUDY18080007) and all participants provided
written informed consent. Study data were collected and managed using
REDCap electronic data capture tools hosted at the University of
Pittsburgh. The study protocol was registered with Clinicaltrials.gov
(NCT03749746) before any enrollment of participants. A data safety and
monitoring committee provided study oversight. There were no adverse
events reported.