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D.A. was an employee and stockholder of Satsuma at the time of study conduct and is now a consultant for Satsuma. J.A. is an advisor for AbbVie, Amgen, Aeon, Axsome, Biohaven, BioDelivery Scientific International, Eli Lilly, GlaxoSmithKline, Lundbeck, Linpharma, Impel, Miravio, Pfizer, Neurolief, Satsuma, Teva, and Theranica; holds clinical trial grants from AbbVie, Biohaven, Eli Lilly, Satsuma, and Zosano; has stock options in CtrlM; and is on the editorial boards or steering committee for <i>Current Pain and Headache Reports<\/i>, <i>Medscape<\/i>, <i>NeurologyLive<\/i>, and <i>SELF<\/i> magazine. L.K. was a consulting medical monitor for Satsuma at the time of the study conduct but owns no shares of Satsuma. His clients include Advarra Consulting, Clinilabs, Q Therapeutics, Thievon-Wright consulting, and Worldwide Clinical Trials. He sits on the advisory boards of Alzheon, INDRC, and Reservoir Pharma. S.S. is an employee of Satsuma and was a stockholder at the time of study conduct. A.M.R. is an advisor for AbbVie, Biohaven, Cala Health, Doctor Reddy\u2019s, Eli Lilly, Pfizer, Satsuma, Teva, Theranica, and Zosano; he is on the speaker\u2019s bureau of AbbVie, Biohaven, Doctor Reddy\u2019s, Lundbeck, Pfizer, and Teva; is the Editor-in-Chief of <i>Neurology Reviews<\/i>; and is on the editorial board of <i>CNS Drugs<\/i>. A.M.R. was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest"}},{"value":"The protocol was approved by the central institutional review board (Advarra) and\/or the ethics committee or institutional review board of each study center.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"All participants provided written informed consent.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code Availability"}},{"value":"The data that support the findings of this study are available from the corresponding author (D.A.) upon reasonable request.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data Availability"}},{"value":"All authors made substantial contributions to the conception and design of the work and the interpretation of the data. The study statistician, Shelia Ligozio, performed the data analyses. All authors participated in the drafting and revising of the manuscript. All authors read and approved the final manuscript.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author Contributions"}}]}}