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.