We thank the study participants and all those involved in analyzing the data.
This study and the Rapid Service Fee for submission were sponsored by Allergan (prior to its acquisition by AbbVie).
Medical writing and/or Editorial Assistance
Writing and editorial assistance was provided to the authors by Lela Creutz, PhD, and Cory R. Hussar, PhD, of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, and was funded by AbbVie.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
This manuscript is based in part on work that has been previously presented at the American Headache Society 61st Annual Scientific Meeting, July 11–14, 2019; 19th Congress of the International Headache Society, September 5–8, 2019; 13th Annual Headache Cooperative of the Pacific, January 24–25, 2020; the Diamond Headache Clinic Research & Educational Foundation’s 2020 Meeting, February 14–17, 2020; the American Headache Society Virtual Annual Scientific Meeting, June 2020; 72nd Annual Meeting of the American Academy of Neurology, April 25–May 1, 2020 (virtual); the American Headache Society Virtual Annual Scientific Meeting, June 13, 2020; AANPconnect: An Online Conference Experience, September 10–December 31, 2020; and the American Academy of Family Physicians FMX Family Medicine Experience, October 13–17, 2020 (virtual).
Susan Hutchinson has served on advisory boards for AbbVie, Alder, Amgen, Avanir, Biohaven, electroCore, Eli Lilly, Supernus, Theranica, Teva, and Upsher-Smith. She is on the speakers bureau for AbbVie, Amgen, Avanir, electroCore, Eli Lilly, Promius, Supernus, and Teva. David W. Dodick reports the following conflicts within the past 12 months: consulting: AbbVie, AEON, Amgen, Clexio, Cerecin, Cooltech, Ctrl M, Alder, Biohaven, Linpharma, Lundbeck, Promius, Eli Lilly, eNeura, Novartis, Impel, Satsuma, Theranica, WL Gore, Nocira, XoC, Zosano, Upjohn (Division of Pfizer), Pieris, Praxis, Revance, Equinox; honoraria: CME Outfitters, Curry Rockefeller Group, DeepBench, Global Access Meetings, KLJ Associates, Academy for Continued Healthcare Learning, Majallin LLC, Medlogix Communications, MJH Lifesciences, Miller Medical Communications, Southern Headache Society (MAHEC), WebMD Health/Medscape, Wolters Kluwer, Oxford University Press, Cambridge University Press; research support: Department of Defense, National Institutes of Health, Henry Jackson Foundation, Sperling Foundation, American Migraine Foundation, Patient Centered Outcomes Research Institute (PCORI); stock options/shareholder/patents/Board of Directors: Ctrl M (options), Aural analytics (options), ExSano (options), Palion (options), Healint (options), Theranica (options), Second Opinion/Mobile Health (options), Epien (options/Board), Nocira (options), Matterhorn (shares/board), Ontologics (shares/board), King-Devick Technologies (options/board), Precon Health (options/board); patent 17189376.1-1466:vTitle: Botulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis. Christina Treppendahl has served on advisory boards/speaker bureaus for AbbVie, Alder, Amgen/Novartis, Avanir Pharmaceuticals, Biohaven, Depomed Inc, electroCore, Eli Iroko Pharmaceuticals, Lilly, Impax Labs, Impel NeuroPharma, the National Headache Foundation, Pernix, Promius Pharma, Supernus Pharmaceuticals, Teva Pharmaceutical Industries, Upsher-Smith Laboratories, Zogenix, and Zosano Pharma. She has served as Principal Investigator for clinical trials including AbbVie, Alder, Avanir, electroCore, Novartis, Patient-Centered Outcomes Research Institute, Teva, and Theranica. Nathan L. Bennett has completed clinical research for AbbVie, Amgen, Avanir, electroCore, Impax, Lilly, and Teva; has consulted or acted on an advisory board for AbbVie, Amgen, Lilly, Pernix, Promius, and Supernus; and has been a speaker for AbbVie, Amgen, Avanir, Promius, Supernus, and Teva. Sung Yun Yu, Hua Guo, and Joel M. Trugman are employees of AbbVie, and may hold AbbVie stock.
Compliance with Ethics Guidelines
The ACHIEVE I and ACHIEVE II trials were conducted in conformance with the principles of the Helsinki Declaration of 1964 and its later amendments, or the laws and regulations of the country in which the research was conducted, whichever afforded the greater protection to the individual. Trial protocols were approved by each individual research center’s institutional review board. All participants provided written informed consent before initiation of trial procedures.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and Clinical Study Reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications
This clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the following link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html