Trial design and oversight
ADVERSE EVENT
The trial was a pragmatic, single center, blinded, placebo controlled, randomized clinical trial. The trial protocol has been previously published [In accordance with IRB approval, patients were approached to obtain written informed consent prior to study enrollment or treatment. The trial was overseen by the Principal Investigator (PI). Adverse events were identified by study personnel, reviewed by the PI, then by a study monitor, who then made recommendations to a data and safety monitoring board (DSMB) who made final recommendations regarding study continuation or termination.