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Russo disclose receiving consulting fees and honoraria from the study sponsor relating to activities outside of this study. Vahid Mohabbati, Marc A. Russo, Charles D. Brooker, James Yu, Richard Sullivan, and Peter Georgius are investigators in the study and as such receive payments at fair-market value from the sponsor for study related activities. Marc A. Russo reports leadership roles in professional neuromodulation societies and equity interests in medical device companies. Richard Sullivan reports receiving honoraria for teaching and educational activities outside the submitted work. Peter Georgius reports consulting and advisory roles, travel support, and intellectual property interests outside the submitted work. James Yu reports a leadership role with the Neuromodulation Society of Australia and New Zealand. Bonnie Ditterline, Malgorzata Siorek and Jessica Friedman are employees of Medtronic.","order":1,"name":"Ethics","label":"Conflict of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The Closed-Loop study was approved by Bellberry Human Research Ethics Committee on 09 November 2021 (Reference # 2021-08-959). The Closed-Loop study was designed and executed in accordance with the principles outlined in the Declaration of Helsinki and applicable regulatory requirements. All participants provided written informed consent prior to enrollment in the Closed-Loop study.","order":2,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}}]}}