Acknowledgments. The authors are grateful to Joe Massaro, professor of biostatistics, mathematics, and statistics at Boston University and director of biostatistics and data management at Harvard Clinical Research Institute, for his independent statistical analyses for this publication. The authors are also indebted to Brian Levy for his thoughtful review and expert feedback on the manuscript.

Funding and Duality of Interest. This study was funded by Nevro Corp. E.A.P. has received consulting fees from Abbott, Medtronic, Neuros Medical, Nevro, Saluda Medical, and Vertos and research support from Medtronic, Neuros Medical, Nevro, ReNeuron, and Saluda Medical. J.A.S. has received research support from Boston Scientific, Nevro, Saluda Medical, and Vertiflex. J.L.W. has received consulting fees from Lilly and Calibr. S.M.S. has received research support from Nevro. K.A. has received consulting fees from Nevro, Nalu, Saluda Medical, Biotronik, and Medtronic and research support from Nevro, Biotronik, Vivex, Saluda Medical, and SPR Therapeutics. M.N.G. has received consulting fees from Nevro, Saluda Medical, and Avanos and research support from Abbott, Saluda Medical, Neuros, Nevro, Nalu, and Avanos. J.X. has received research support from Nevro and National Institutes of Health K08 grant CA228039. C.Y. has received research support from Nevro. A.N. has received consulting fees from Flowonix and Nevro and research support from Nevro. D.G.P. has received consulting fees from Abbott, AIS, Allergan, Amgen, and CornerLoc and research support from Abbott, Biotronik, Flowonix, Nevro, Nuvectra, and Vertiflex. N.D.M. has received consulting fees from Nevro, Salix Pharma, Biodelivery Sciences, and Averitas and research support from Boston Scientific, Medtronic, and Nevro. D.S. has received consulting fees from Abbott, Boston Scientific, Nevro, Vertos, and Vertiflex and research support from Abbott, Biotronic, Nevro, Vertos, and Vertiflex. S.P.L. has received consulting fees from Nevro. J.H.G. has received consulting fees from Stratus Medical and Abbott and research support from SPR Therapeutics and Mainstay Medical. C.E.A. has received consulting fees from Nevro, Vertex, Lilly, Pfizer, and Teva and research support from Allergan, Amgen, DSI, Lilly, Novartis, and Teva. C.E.N. has received consulting fees from Siemens Healthineers, Horizon Therapeutics, Nevro, Neurogastrx, and Exelixis. R.S.T. has received consulting fees from Medtronic, Nevro, and Saluda Medical. N.A.M. has received consulting fees from Boston Scientific, Sollis Therapeutics, Saluda Medical Medical, Nevro, Abbott (formerly Spinal Modulation), Vertos Medical, Nuvectra, and Relievant Medsystems; is a Medical Monitor for Mainstay’s RESTORE clinical trial; and has received research support from Avanos “Halyard,” Mallinckrodt, Mesoblast, and Neuros Medical. E.S.B. and D.L.C. are employees of Nevro Corp. No other potential conflicts of interest relevant to this article were reported.

Author Contributions. E.S.B., K.A., M.N.G., V.G., R.H.B., C.E.A., C.E.N., R.S.T., D.L.C., and N.A.M. contributed to the conception and design of the study. E.A.P., T.G.S., J.A.S., J.L.W., S.M.S., K.A., M.N.G., J.X., C.Y., A.N., D.G.P., K.C.T., M.J.C., V.G., R.H.B., N.D.M., D.S., S.P.L., D.J.D., K.A.S., J.H.G., M.T.B., N.J.H., A.F.I., P.C., and P.W.W. recruited subjects and acquired data. E.A.P., E.S.B., C.E.A., C.E.N., R.S.T., D.L.C., and N.A.M. were involved in the analysis and interpretation of the data along with an independent biostatistician. All authors reviewed the manuscript critically and approved of its content. E.A.P. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Prior Presentation. Parts of this study were presented in abstract form at the American Diabetes Association 81st Scientific Sessions, held virtually 25–29 June 2021; the North American Neuromodulation Society Mid-Year Meeting, Orlando, FL, 15–17 July 2021; the American Society of Pain & Neuroscience Annual Conference, Miami Beach, FL, 22–25 July 2021; the Neuromodulation Society of Australia and New Zealand 14th Annual Scientific Meeting, held virtually 14–15 August 2021; the European Association for the Study of Diabetes Annual Meeting, held virtually 28 September to 1 October 2021; the Congress of Neurological Surgeons Annual Meeting, Austin, TX, 16-20 October 2021; and the Diabetic Foot Conference, San Francisco, CA, 21-23 October 2021.