Study design and participants
This was a multicenter single-blinded study performed in accordance with guidelines and oversight from the FDA, and under the management of a contracted research organization. Study approval was obtained from the Western Institutional Review Board and by Duke and Emory University’s institutional review board. In accordance with the FDA, an investigational new drug application was filed, #18414, which referenced investigator device exemption #17894. The study was also registered with ClinicalTrials.gov, A total of 570 patients were screened to identify 480 eligible patients who were randomized at five clinical sites in five different states within the United States. The five clinical sites included clinics from Emory, Sanford (two sites), Andrews Institute, and Duke. For a consort diagram of participants entered in study, see Fig. 