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Article History

Received: 9 June 2022

Accepted: 11 October 2022

First Online: 25 October 2022

Declarations

:

: The PROMISE-1 study was approved by the independent ethics committee or institutional review board for each of the 87 study sites: Birmingham, Alabama, United States, 35216; Phoenix, Arizona, United States, 85013; Tucson, Arizona, United States, 85712; Little Rock, Arkansas, United States, 72205; Anaheim, California, United States, 92801; Fresno, California, United States, 93702; Fullerton, California, United States, 92835; Long Beach, California, United States, 90806; Montclair, California, United States, 91763; Oceanside, California, United States, 92056; Redlands, California, United States, 92374; two sites in San Diego, California, United States: 92103; 92108; Santa Monica, California, United States, 90404; Sherman Oaks, California, United States, 91403; Colorado Springs, Colorado, United States, 80918; Fort Collins, Colorado, United States, 80528; Stamford, Connecticut, United States, 06905; Waterbury, Connecticut, United States, 06708; Bradenton, Florida, United States, 34201; DeLand, Florida, United States, 32720; Fort Myers, Florida, United States, 33912; Hallandale Beach, Florida, United States, 33009; Hialeah, Florida, United States, 33012; Maitland, Florida, United States, 32751; three sites in Miami, Florida, United States: 33143; 33155; 33173; Naples, Florida, United States, 34102; Orlando, Florida, United States, 32801; Sunrise, Florida, United States, 33351; Winter Haven, Florida, United States, 33880; two sites in Atlanta, Georgia, United States: 30331; 30342; Stockbridge, Georgia, United States, 30281; Chicago, Illinois, United States, 60607; Lisle, Illinois, United States, 60532; Prairie Village, Kansas, United States, 66206; Lexington, Kentucky, United States, 40509; Owensboro, Kentucky, United States, 42303; New Orleans, Louisiana, United States, 70115; Boston, Massachusetts, United States, 02131; North Attleboro, Massachusetts, United States, 02760; Springfield, Massachusetts, United States, 01104; Watertown, Massachusetts, United States, 02472; Ann Arbor, Michigan, United States, 48104; Farmington Hills, Michigan, United States, 48334; Jackson, Michigan, United States, 49201; Minneapolis, Minnesota, United States, 55402; Flowood, Mississippi, United States, 39232; Saint Louis, Missouri, United States, 63141; Springfield, Missouri, United States, 65807; Las Vegas, Nevada, United States, 89119; Reno, Nevada, United States, 89502; Albuquerque, New Mexico, United States, 87102; two sites in Brooklyn, New York, United States: 11213; 11229; Hartsdale, New York, United States, 10530; Rochester, New York, United States, 14609; Staten Island, New York, United States, 10312; Durham, North Carolina, United States, 27713; Greensboro, North Carolina, United States, 27405; High Point, North Carolina, United States, 27265; Wilmington, North Carolina, United States, 28401; Dayton, Ohio, United States, 45424; Edmond, Oklahoma, United States, 73034; Norman, Oklahoma, United States, 73069; Oklahoma City, Oklahoma, United States, 73112; Portland, Oregon, United States, 97210; Allentown, Pennsylvania, United States, 18104; Smithfield, Pennsylvania, United States, 15478; Anderson, South Carolina, United States, 29621; two sites in Chattanooga, Tennessee, United States: 37404; 37421; Kingsport, Tennessee, United States, 37660; Memphis, Tennessee, United States, 38119; Austin, Texas, United States, 78745; Dallas, Texas, United States, 75231; two sites in Houston, Texas, United States: 77074; 77081; Richmond, Virginia, United States, 23294; Virginia Beach, Virginia, United States, 23454; Bellevue, Washington, United States, 98007; and four sites in Tbilisi, Georgia: 0112; 0160; 0179; 0186. The PROMISE-2 study was approved by the independent ethics committee or institutional review board for each of the 145 study sites: Birmingham, Alabama, United States, 35235; Phoenix, Arizona, United States, 85032; Little Rock, Arkansas, United States, 72211; Carlsbad, California, United States, 92011; Oceanside, California, United States, 92056; Orange, California, United States, 92868; Oxnard, California, United States, 93030; Palo Alto, California, United States, 94304; Redlands, California, United States, 92374; San Diego, California, United States, 92108; Santa Monica, California, United States, 90404; Torrance, California, United States, 90502; Colorado Springs, Colorado, United States, 80918; New London, Connecticut, United States, 06320; Jacksonville, Florida, United States, 32256; Miami, Florida, United States, 33155; Orlando, Florida, United States, 32806; Tampa, Florida, United States, 33606; West Palm Beach, Florida, United States, 33407; Winter Haven, Florida, United States, 33880; two sites in Atlanta, Georgia, United States: 30328; 30342; Decatur, Georgia, United States, 30030; Champaign, Illinois, United States, 61820; two sites in Chicago, Illinois, United States: 60607; 60642; Anderson, Indiana, United States, 46011; Des Moines, Iowa, United States, 50309; Overland Park, Kansas, United States, 66212; Prairie Village, Kansas, United States, 66208; Wichita, Kansas, United States, 67207; Marrero, Louisiana, United States, 70072; Waldorf, Maryland, United States, 20603; Boston, Massachusetts, United States, 02135; North Attleboro, Massachusetts, United States, 02740; Watertown, Massachusetts, United States, 02472; Ann Arbor, Michigan, United States, 48104; Minneapolis, Minnesota, United States, 55402; Flowood, Mississippi, United States, 39232; Saint Louis, Missouri, United States, 63141; Saint Peters, Missouri, United States, 63303; Springfield, Missouri, United States, 65810; Las Vegas, Nevada, United States, 89113; Lebanon, New Hampshire, United States, 03756; Princeton, New Jersey, United States, 08540; Albuquerque, New Mexico, United States, 87102; Amherst, New York, United States, 14226; Brooklyn, New York, United States, 11229; two sites in New York, New York, United States: 10016; 10019; Plainview, New York, United States, 11803; Rochester, New York, United States, 14609; Durham, North Carolina, United States, 27705; High Point, North Carolina, United States, 27262; Canton, Ohio, United States, 44718; Dayton, Ohio, United States, 45432; Oklahoma City, Oklahoma, United States, 73116; Scottdale, Pennsylvania, United States, 15683; Smithfield, Pennsylvania, United States, 15478; Mount Pleasant, South Carolina, United States, 29464; two sites in Chattanooga, Tennessee, United States: 37404; 37421; Memphis, Tennessee, United States, 38119; Nashville, Tennessee, United States, 37203; Dallas, Texas, United States, 75214; Houston, Texas, United States, 77058; Houston, Texas, United States, 77081; North Richland Hills, Texas, United States, 76180; San Antonio, Texas, United States, 78258; two sites in Salt Lake City, Utah, United States: 84109; 84123; Richmond, Virginia, United States, 23294; Bellevue, Washington, United States, 98007; Spokane, Washington, United States, 99202; Brussels, Belgium, 1090; two sites in Liege, Belgium, 4000; Brno, Czechia, 61500; Choceň, Czechia, 565 01; Prague, Czechia, 18200; Praha, Czechia, 100 34; Glostrup, Denmark, 2600; Viborg, Denmark, 8800; four sites in Tbilisi, Georgia: 0112; 0160; 0179; 0186; Berlin, Germany, 10117; Erlangen, Germany, 91054; Hamburg, Germany, 20246; Nordheim, Germany, 45122; Unterhaching, Germany, 82008; three sites in Budapest, Hungary: 1033; 1083; 1145; Pecs, Hungary, 7623; Ancona, Italy, 60020; two sites in Milano, Italy: 20132; 20133; Napoli, Italy, 80131; Pavia, Italy, 27100; Roma, Italy, 00163; Ekaterinburg, Russian Federation, 620102; Kazan', Russian Federation, 420064; Krasnoyarsk, Russian Federation, 660037Moscow, Russian Federation, 121467; two sites in Novosibirsk, Russian Federation, 630051; 630054; three sites in Saint Petersburg, Russian Federation: 191144; 194044; 194223; Yaroslavl', Russian Federation, 150030; Banska Bystrica, Slovakia, 97404Dolný Kubín, Slovakia, 026 01; Dubnica nad Vahom, Slovakia, 01841; Krompachy, Slovakia, 053 42; Alicante, Spain, 03010; Barcelona, Spain, 08035; Guadalajara, Spain, 19002; Lleida, Spain, 25198; four sites in Madrid, Spain: 28046; 28050; 28222; 28223; Navarrés, Spain, 31008; Santander, Spain, 39008; Sevilla, Spain, 41013; Terrassa, Spain, 08221; Valencia, Spain, 46026; Valladolid, Spain, 47005; two sites in Dnipropetrovs'k, Ukraine: 49045; 49027; Ivano-Frankivs'k, Ukraine, 76008; two sites in Kharkiv, Ukraine: 61068; 61103; L'viv, Ukraine, 79010; Odessa, Ukraine, 65014; Vinnytsia, Ukraine, 21005; Zaporizhzhya, Ukraine, 69065; Glasgow, United Kingdom, G51 4TF; Inverness, United Kingdom, IV2 3UJ; London, United Kingdom, SE5 9PL; Newcastle, United Kingdom, NE1 4LP; Salford, United Kingdom, M8 8HD; and Stoke-on-Trent, United Kingdom, ST4 7LN. Both studies were conducted in accordance with standards of Good Clinical Practice as defined by the International Conference on Harmonisation and all applicable federal and local regulations. All study documentation was approved by the local review board at each site or by a central institutional review board or ethics committee. All patients provided written informed consent prior to participation in their respective study.

: Not applicable.

: PP-R has received honoraria as a consultant and speaker from Allergan/AbbVie, Biohaven, Chiesi, Eli Lilly, Medscape, Lundbeck, Novartis, and Teva Pharmaceuticals. Her research group has received research grants from AGAUR, Allergan/AbbVie, EraNet Migraine Research Foundation, FEDER RIS3CAT, Instituto Investigación Carlos III, International Headache Society, la Caixa foundation, MICINN, Neuron, Novartis, PERIS, and Teva; and has received funding for clinical trials from Alder, Allergan/AbbVie, Amgen, electroCore, Eli Lilly, Lundbeck, Novartis, and Teva. She is the Honorary Secretary of the International Headache Society. She is on the editorial board of <i>Revista de Neurologia</i>. She is an associate editor for <i>Cephalalgia</i>, <i>Headache</i>, <i>Neurologia,</i> and <i>Frontiers of Neurology</i> and an advisory Scientific member of the Editorial Board of <i>The Journal of Headache and Pain.</i> She is a member of the Clinical Trials Guidelines Committee and Scientific Committee of the International Headache Society. She has edited the Guidelines for the Diagnosis and Treatment of Headache of the Spanish Neurological Society. She is the founder of ExternalRef removed. PP-R does not own stocks from any pharmaceutical company.DD has been a consultant for Amgen, Allergan/Abbvie, Atria Health, AYYA Biosciences, Biohaven, CapiThera Ltd., Cerecin, Ceruvia Lifesciences LLC, Cooltech, Ctrl M, Eli Lilly, GSK, Impel, Lundbeck, Nocira, Novartis, Perfood, Pfizer, Praxis, Revance, Satsuma, Theranica, and WL Gore. He has received payment or honoraria from Amgen, Allergan/Abbvie, Biohaven, Cambridge University Press, Clinical Care Solutions, CME Outfitters, Curry Rockefeller Group, DeepBench, Eli Lilly, Global Access Meetings, KLJ Associates, Lundbeck, Majallin LLC, Medlogix Communications, Miller Medical Communications, MJH Lifesciences, Novartis, Oxford University Press, Pfizer, Vector Psychometric Group, WebMD Health/Medscape, and Wolters Kluwer. He has participated on Data Safety Monitoring or Advisory Boards for Allergan/Abbvie, Academy for Continued Healthcare Learning, Amgen, and Biohaven. He has received research support from American Migraine Foundation, Department of Defense, Henry Jackson Foundation, National Institutes of Health, Patient Centered Outcomes Research Institute (PCORI), and Sperling Foundation. He has a leadership or fiduciary role with American Brain Foundation, American Migraine Foundation, International Headache Society, and Global Patient Advocacy Coalition. He owns stock or stock options in Atria Health, Aural Analytics, AYYA Biosciences, Epien, ExSano, Healint, King-Devick Technologies, Man and Science, Matterhorn, Nocira, Ontologics, Precon Health, Second Opinion/Mobile Health, and Theranica. He holds a patent, 17189376.1–1466:vTitle: Botulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis without fee, and has a patent application submitted, Synaquell (Precon Health). AE is a full-time employee of H. Lundbeck A/S. JH is an employee of Pacific Northwest Statistical Consulting, Inc., a contracted service provider of biostatistical resources for Lundbeck. RC was an employee of Lundbeck at the time of manuscript development.