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Pope reports research and consulting fees from Saluda Medical during the conduct of the study; consultancy for Abbott, Medtronic, Saluda Medical, Flowonix, SpineThera, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, and Thermaquil outside the submitted work; has received grant and research support from: Abbott, Flowonix, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, and Thermaquil outside the submitted work; and is a minority shareholder of Vertos, Stimgenics, SPR Therapeutics, Saluda Medical, Painteq, Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil, Abbott and Anesthetic Gas Reclamation. Chau M. Vu is a consultant for Saluda Medical and PainTEQ. Johnathan H. Goree is a consultant for Saluda Medical, Abbott, and Stratus Medical. Eric G. Cornidez reports consulting for Abbott, Boston Scientific, NEVRO, and Saluda Medical and research and consulting for NALU. Drew Trainor reports being a consultant for Saluda Medical. Abeer Khurram, Ian Gould, and Dean M. Karantonis report being employees of Saluda Medical.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"The ECAP Study (NCT04319887, registered 24\u00a0March 2020 on ClinicalTrials.gov, first enrollment 29 October 2020) was conducted in accordance with the United States Food and Drug Administration (FDA) regulatory requirements, good clinical practice (GCP, per ISO 14155), Western Institutional Review Board approval (WIRB ID 1290548), and the Declaration of Helsinki guided ethical principles. All patients provided written informed consent prior to participation in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}