Ethics approval and consent to participate

The ADVANCE and LTS trials were approved by an institutional review board or independent ethics committee and registered at ClinicalTrials.gov: NCT03777059 (ADVANCE) and NCT03700320 (LTS trial). For each trial, participants provided written informed consent. All study conduct was in accordance with the International Conference on Harmonisation Guidelines for Good Clinical Practice.

Consent for publication

Not applicable.

Competing interests

RBL has received research support from the National Headache Foundation, the National Institutes of Health, and the US Food and Drug Administration. He serves as consultant for, advisory board member of, or has received honoraria or research support from AbbVie/Allergan, Amgen, Biohaven, Dr. Reddy’s Laboratories (Promius), electroCore, Eli Lilly, GlaxoSmithKline, Lundbeck, Merck, Novartis, Teva, Vector, and Vedanta Research. He receives royalties from Wolff’s Headache, 8th edition (Oxford University Press, 2009), and Informa. He holds stock/options in Biohaven and Manistee. SJN has served as consultant for AbbVie, Eli Lilly, Lundbeck, Pfizer, Theranica, and Tonix. She has received honoraria for work in education or publishing from American Academy of Neurology, American Headache Society, Diamond Headache Clinic Research and Educational Foundation, MedLink Neurology, MJH Life Sciences, NACCME, Springer, WebMD/Medscape, and Wolters Kluwer. PP-R has received, in the last 3 years, personal fees for advisory boards and speaker panels from AbbVie, Amgen, Chiesi, Eli Lilly, Lundbeck, Medscape, Novartis, Pfizer, and Teva, and for serving on the scientific advisory board of Lilly Foundation Spain and Gadea Science Foundation. She is the principal investigator for clinical trials sponsored by AbbVie, Amgen, Biohaven, Eli Lilly, Lundbeck, Novartis, and Teva. Her group has received grants from AbbVie, Era-Net Neuron, European Commission, Instituto Carlos III, International Headache Society, MINECO, Novartis, FEDER RIS3CAT, and Teva. She serves as an associate editor for Cephalalgia, Headache, Neurologia, The Journal of Headache and Pain, and Revista de Neurologia. She is the Honorary Secretary of the International Headache Society. She does not hold any stock or options. TB has participated in advisory boards for AbbVie, Biohaven, and Theranica. She is a clinical trial investigator for Lundbeck. PM has received research funding from AbbVie, Amgen, Biogen, Biohaven, EMD Serono, Lundbeck, Novartis, and Teva, and has received personal compensation for advisory boards and/or speakers bureaus for AbbVie, Aeon, Amgen, Biohaven, Lilly, Lundbeck, Revance, and Teva. MF was an employee of AbbVie at the time of study conduct and may hold AbbVie stock. DWD reports the following conflicts: Consulting: Amgen, Atria, CapiThera Ltd., Cerecin, Ceruvia Lifesciences LLC, CoolTech, Ctrl M, Allergan, AbbVie, Biohaven, Escient, GlaxoSmithKline, Halion, Lundbeck, Eli Lilly, Novartis, Impel, Satsuma, Theranica, WL Gore, Genentech, Nocira, Perfood, Praxis, AYYA Biosciences, Revance, Pfizer. Honoraria: American Academy of Neurology, Headache Cooperative of the Pacific, Headache Cooperative of New England, Canadian Headache Society, MF Med Ed Research, Biopharm Communications, CEA Group Holding Company (Clinical Education Alliance LLC), Teva (speaking), Amgen Japan (speaking), Eli Lilly Canada (speaking), Lundbeck (speaking), Pfizer (speaking), Vector Psychometric Group, Clinical Care Solutions, CME Outfitters, Curry Rockefeller Group, DeepBench, Global Access Meetings, KLJ Associates, Academy for Continued Healthcare Learning, Majallin LLC, Medlogix Communications, Medica Communications LLC, MJH Lifesciences, Miller Medical Communications, WebMD Health/Medscape, Wolters Kluwer, Oxford University Press, Cambridge University Press. Non-profit board membership: American Brain Foundation, American Migraine Foundation, ONE Neurology, Precon Health Foundation, Global Patient Advocacy Coalition, Atria Health Collaborative, Atria Academy of Science and Medicine, Arizona Brain Injury Alliance, Domestic Violence HOPE Foundation/Panfila, CSF Leak Foundation. 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), Axon Therapeutics (board/options), ExSano (options), Palion (options), Keimon Medical (options), Man and Science, Healint (options), Theranica (options), Second Opinion/Mobile Health (options), Epien (options), Nocira (options), Matterhorn (shares), Ontologics (shares), King-Devick Technologies (options/board), Precon Health (options/board), ScotiaLyfe (board), EigenLyfe (options/board), AYYA Biosciences (options), Axon Therapeutics (options/board), Cephalgia Group (options/board), Atria Health (options/employee). Patent 17189376.1-1466:vTitle: Onabotulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis (non-royalty bearing). Patent application submitted: Synaquell® (Precon Health). YL, NC, and BD are employees of AbbVie and may hold AbbVie stock.

Data sharing statement

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, clinical study reports, or analysis plans), 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.

These 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, Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time after approval in the US and Europe and after acceptance of this manuscript for publication. 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://vivli.org/ourmember/abbvie/ then select “Home.”