Limitations
This study has several limitations. First, because of slow enrollment related to COVID-19 pandemic, the study was stopped early with sufficient power to address feasibility and tolerability aims, but only partially explore the safety aim. Second, this was a single-center study. A subsequent multicenter trial is planned. Third, the administering technician was not masked to the study assignment, but use of sham control enabled blinding of patients, treating team, and final outcome assessor.