{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,4]],"date-time":"2026-03-04T00:30:33Z","timestamp":1772584233339,"version":"3.50.1"},"reference-count":27,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,12,12]],"date-time":"2024-12-12T00:00:00Z","timestamp":1733961600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,12,12]],"date-time":"2024-12-12T00:00:00Z","timestamp":1733961600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Lundbeck LLC, Deerfield, IL, US"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Neurol"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Introduction<\/jats:title>\n            <jats:p>Longer periods between headache episodes (interictal periods) may provide greater time for the nervous system to reset from a previous episode, potentially improving disease status and health-related quality of life. This post hoc analysis evaluated this hypothesis by associating patients\u2019 longest interictal periods with improvements in patient-reported outcomes.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>PROMISE-2 (NCT02974153) was a double-blind, placebo-controlled study evaluating eptinezumab for preventive treatment of chronic migraine (N\u2009=\u20091072). Daily electronic diary data from Weeks 1\u201312 and Weeks 1\u201324 were used to identify interictal periods, defined as days between headache episodes. For each patient, the longest interictal period within these intervals was identified and categorized (1\u20134, 5\u20139, 10\u201314,\u2009&gt;\u200914, and\u2009&gt;\u200921 days). For each category, the following patient-reported outcomes were assessed: 6-item Headache Impact Test (HIT-6), Patient Global Impression of Change (PGIC), and patient-identified most bothersome symptom (PI-MBS).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>Excluding interictal periods with\u2009&gt;\u200910% missing data (resulting in 1010 patients with sufficient data), the mean (SD) of longest interictal periods over Weeks 1\u201312 was 9.4 (11.0) days. A \u22656-point HIT-6 reduction was observed in 78% (56\/72) vs 26% (91\/351) of patients with a\u2009&gt;\u200921-day vs 1\u20134-day longest interictal period, respectively; much or very much improvement per PGIC was reported in 90% (65\/72) vs 25% (87\/348), respectively, and per PI-MBS was reported in 88% (63\/72) vs 26% (92\/348), respectively. Similar results were observed for Weeks 1\u201324.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion<\/jats:title>\n            <jats:p>Longer interictal periods were associated with more patients indicating positive changes in headache-related life impact, disease status, and symptomology.<\/jats:p>\n            <jats:p>\n              <jats:bold>Trial registration:<\/jats:bold> ClinicalTrials.gov (identifier: NCT02974153; registered: 2016-11-23)<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s00415-024-12809-z","type":"journal-article","created":{"date-parts":[[2024,12,12]],"date-time":"2024-12-12T11:27:35Z","timestamp":1734002855000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Eptinezumab treatment was associated with longer interictal headache\/migraine periods which corresponded to greater improvements in patient-reported quality of life measures"],"prefix":"10.1007","volume":"272","clinical-trial-number":[{"clinical-trial-number":"nct02974153","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9879-6638","authenticated-orcid":false,"given":"Stewart J.","family":"Tepper","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Merle L.","family":"Diamond","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joe","family":"Hirman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Divya","family":"Asher","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Damian","family":"Fiore","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4081-8395","authenticated-orcid":false,"given":"Roger","family":"Cady","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,12,12]]},"reference":[{"key":"12809_CR1","doi-asserted-by":"publisher","first-page":"137","DOI":"10.1186\/s10194-020-01208-0","volume":"21","author":"TJ Steiner","year":"2020","unstructured":"Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z, The L, Burden: the Global Campaign against H, (2020) Migraine remains second among the world\u2019s causes of disability, and first among young women: findings from GBD2019. J Headache Pain 21:137. https:\/\/doi.org\/10.1186\/s10194-020-01208-0","journal-title":"J Headache Pain"},{"key":"12809_CR2","doi-asserted-by":"publisher","first-page":"2","DOI":"10.1038\/s41572-021-00328-4","volume":"8","author":"MD Ferrari","year":"2022","unstructured":"Ferrari MD, Goadsby PJ, Burstein R, Kurth T, Ayata C, Charles A, Ashina M, van den Maagdenberg A, Dodick DW (2022) Migraine. Nat Rev Dis Primers 8:2. https:\/\/doi.org\/10.1038\/s41572-021-00328-4","journal-title":"Nat Rev Dis Primers"},{"key":"12809_CR3","doi-asserted-by":"publisher","unstructured":"Headache Classification Committee of the International Headache Society (IHS) (2018) The International Classification of Headache Disorders, 3rd edition. Cephalalgia 38: 1\u2013211. https:\/\/doi.org\/10.1177\/0333102417738202","DOI":"10.1177\/0333102417738202"},{"key":"12809_CR4","doi-asserted-by":"publisher","first-page":"297","DOI":"10.1586\/14737175.6.3.297","volume":"6","author":"ME Bigal","year":"2006","unstructured":"Bigal ME, Lipton RB (2006) When migraine progresses: transformed or chronic migraine. Expert Rev Neurother 6:297\u2013306. https:\/\/doi.org\/10.1586\/14737175.6.3.297","journal-title":"Expert Rev Neurother"},{"key":"12809_CR5","doi-asserted-by":"publisher","first-page":"866","DOI":"10.1177\/0333102419898868","volume":"40","author":"KP Peng","year":"2020","unstructured":"Peng KP, May A (2020) Redefining migraine phases\u2014a suggestion based on clinical, physiological, and functional imaging evidence. Cephalalgia 40:866\u2013870. https:\/\/doi.org\/10.1177\/0333102419898868","journal-title":"Cephalalgia"},{"key":"12809_CR6","doi-asserted-by":"publisher","first-page":"57","DOI":"10.1007\/s11916-010-0165-z","volume":"15","author":"SK Aurora","year":"2011","unstructured":"Aurora SK, Kulthia A, Barrodale PM (2011) Mechanism of chronic migraine. Curr Pain Headache Rep 15:57\u201363. https:\/\/doi.org\/10.1007\/s11916-010-0165-z","journal-title":"Curr Pain Headache Rep"},{"key":"12809_CR7","doi-asserted-by":"publisher","first-page":"426","DOI":"10.1111\/j.1526-4610.2004.04094.x","volume":"44","author":"RK Cady","year":"2004","unstructured":"Cady RK, Schreiber CP, Farmer KU (2004) Understanding the patient with migraine: the evolution from episodic headache to chronic neurologic disease. A proposed classification of patients with headache. Headache 44:426\u2013435. https:\/\/doi.org\/10.1111\/j.1526-4610.2004.04094.x","journal-title":"Headache"},{"key":"12809_CR8","doi-asserted-by":"publisher","first-page":"e1365","DOI":"10.1212\/WNL.0000000000009169","volume":"94","author":"RB Lipton","year":"2020","unstructured":"Lipton RB, Goadsby PJ, Smith J, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Cady R (2020) Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology 94:e1365\u2013e1377. https:\/\/doi.org\/10.1212\/WNL.0000000000009169","journal-title":"Neurology"},{"key":"12809_CR9","unstructured":"Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine (PROMISE 2). ClinicalTrials.gov identifier: NCT02974153. Updated June 9, 2020. https:\/\/clinicaltrials.gov\/study\/NCT02974153. Accessed: February 6, 2024"},{"key":"12809_CR10","doi-asserted-by":"publisher","first-page":"e00567","DOI":"10.1002\/prp2.567","volume":"8","author":"B Baker","year":"2020","unstructured":"Baker B, Schaeffler B, Beliveau M, Rubets I, Pederson S, Trinh M, Smith J, Latham J (2020) Population pharmacokinetic and exposure-response analysis of eptinezumab in the treatment of episodic and chronic migraine. Pharmacol Res Perspect 8:e00567. https:\/\/doi.org\/10.1002\/prp2.567","journal-title":"Pharmacol Res Perspect"},{"key":"12809_CR11","doi-asserted-by":"publisher","first-page":"963","DOI":"10.1023\/a:1026119331193","volume":"12","author":"M Kosinski","year":"2003","unstructured":"Kosinski M, Bayliss MS, Bjorner JB, Ware JE Jr, Garber WH, Batenhorst A, Cady R, Dahlof CG, Dowson A, Tepper S (2003) A six-item short-form survey for measuring headache impact: the HIT-6. Qual Life Res 12:963\u2013974. https:\/\/doi.org\/10.1023\/a:1026119331193","journal-title":"Qual Life Res"},{"key":"12809_CR12","doi-asserted-by":"publisher","first-page":"2003","DOI":"10.1111\/head.13946","volume":"60","author":"CR Houts","year":"2020","unstructured":"Houts CR, Wirth RJ, McGinley JS, Cady R, Lipton RB (2020) Determining thresholds for meaningful change for the headache impact test (HIT-6) total and item-specific scores in chronic migraine. Headache 60:2003\u20132013. https:\/\/doi.org\/10.1111\/head.13946","journal-title":"Headache"},{"key":"12809_CR13","unstructured":"Guy W (1976) Clinical Global Impressions (028-CGI). In: Guy W (ed) ECDEU Assessment Manual for Psychopharmacology. U.S. Dept. of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, Rockville, MD"},{"key":"12809_CR14","doi-asserted-by":"publisher","first-page":"766","DOI":"10.1111\/head.14120","volume":"61","author":"RB Lipton","year":"2021","unstructured":"Lipton RB, Dodick DW, Ailani J, McGill L, Hirman J, Cady R (2021) Patient-identified most bothersome symptom in preventive migraine treatment with eptinezumab: a novel patient-centered outcome. Headache 61:766\u2013776. https:\/\/doi.org\/10.1111\/head.14120","journal-title":"Headache"},{"key":"12809_CR15","doi-asserted-by":"publisher","first-page":"690","DOI":"10.1111\/head.14295","volume":"62","author":"RB Lipton","year":"2022","unstructured":"Lipton RB, Goadsby PJ, Dodick DW, McGinley JS, Houts CR, Wirth RJ, Kymes S, Ettrup A, Osterberg O, Cady R, Ashina M, Buse DC (2022) Evaluating the clinical utility of the patient-identified most bothersome symptom measure from PROMISE-2 for research in migraine prevention. Headache 62:690\u2013699. https:\/\/doi.org\/10.1111\/head.14295","journal-title":"Headache"},{"key":"12809_CR16","doi-asserted-by":"publisher","first-page":"1100","DOI":"10.1016\/s1474-4422(14)70209-1","volume":"13","author":"DW Dodick","year":"2014","unstructured":"Dodick DW, Goadsby PJ, Silberstein SD, Lipton RB, Olesen J, Ashina M, Wilks K, Kudrow D, Kroll R, Kohrman B, Bargar R, Hirman J, Smith J, ALD403 study investigators (2014) Safety and efficacy of ALD403, an antibody to calcitonin gene-related peptide, for the prevention of frequent episodic migraine: a randomised, double-blind, placebo-controlled, exploratory phase 2 trial. Lancet Neurol 13:1100\u20131107. https:\/\/doi.org\/10.1016\/s1474-4422(14)70209-1","journal-title":"Lancet Neurol"},{"key":"12809_CR17","doi-asserted-by":"publisher","first-page":"1075","DOI":"10.1177\/0333102419858355","volume":"39","author":"DW Dodick","year":"2019","unstructured":"Dodick DW, Lipton RB, Silberstein S, Goadsby PJ, Biondi D, Hirman J, Cady R, Smith J (2019) Eptinezumab for prevention of chronic migraine: a randomized phase 2b clinical trial. Cephalalgia 39:1075\u20131085. https:\/\/doi.org\/10.1177\/0333102419858355","journal-title":"Cephalalgia"},{"key":"12809_CR18","doi-asserted-by":"publisher","first-page":"241","DOI":"10.1177\/0333102420905132","volume":"40","author":"M Ashina","year":"2020","unstructured":"Ashina M, Saper J, Cady R, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Smith J (2020) Eptinezumab in episodic migraine: a randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia 40:241\u2013254. https:\/\/doi.org\/10.1177\/0333102420905132","journal-title":"Cephalalgia"},{"key":"12809_CR19","doi-asserted-by":"publisher","first-page":"597","DOI":"10.1016\/s1474-4422(22)00185-5","volume":"21","author":"M Ashina","year":"2022","unstructured":"Ashina M, Lanteri-Minet M, Pozo-Rosich P, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B (2022) Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol 21:597\u2013607. https:\/\/doi.org\/10.1016\/s1474-4422(22)00185-5","journal-title":"Lancet Neurol"},{"key":"12809_CR20","doi-asserted-by":"publisher","first-page":"1005","DOI":"10.1177\/03331024221089567","volume":"42","author":"P McAllister","year":"2022","unstructured":"McAllister P, Kudrow D, Cady R, Hirman J, Ettrup A (2022) Reduction in migraine-associated burden after eptinezumab treatment in patients with chronic migraine. Cephalalgia 42:1005\u20131012. https:\/\/doi.org\/10.1177\/03331024221089567","journal-title":"Cephalalgia"},{"key":"12809_CR21","doi-asserted-by":"publisher","first-page":"1089","DOI":"10.1111\/ene.15670","volume":"30","author":"PJ Goadsby","year":"2023","unstructured":"Goadsby PJ, Barbanti P, Lambru G, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B (2023) Eptinezumab improved patient-reported outcomes and quality of life in patients with migraine and prior preventive treatment failures. Eur J Neurol 30:1089\u20131098. https:\/\/doi.org\/10.1111\/ene.15670","journal-title":"Eur J Neurol"},{"key":"12809_CR22","doi-asserted-by":"publisher","first-page":"797","DOI":"10.1080\/14737167.2023.2219898","volume":"23","author":"L Jonsson","year":"2023","unstructured":"Jonsson L, Regnier SA, Kymes S, Awad SF, Talon B, Lee XY, Goadsby PJ (2023) Estimating treatment effects on health utility scores for patients living with migraine: a post hoc analysis of the DELIVER trial. Expert Rev Pharmacoecon Outcomes Res 23:797\u2013803. https:\/\/doi.org\/10.1080\/14737167.2023.2219898","journal-title":"Expert Rev Pharmacoecon Outcomes Res"},{"key":"12809_CR23","doi-asserted-by":"publisher","first-page":"155","DOI":"10.1186\/s10194-023-01688-w","volume":"24","author":"M Ashina","year":"2023","unstructured":"Ashina M, Tepper SJ, Gendolla A, Sperling B, Ettrup A, Josiassen MK, Starling AJ (2023) Long-term effectiveness of eptinezumab in patients with migraine and prior preventive treatment failures: extension of a randomized controlled trial. J Headache Pain 24:155. https:\/\/doi.org\/10.1186\/s10194-023-01688-w","journal-title":"J Headache Pain"},{"key":"12809_CR24","doi-asserted-by":"publisher","first-page":"45","DOI":"10.1186\/s10194-024-01752-z","volume":"25","author":"L Jonsson","year":"2024","unstructured":"Jonsson L, Awad SF, Regnier SA, Talon B, Kymes S, Lee XY, Goadsby PJ (2024) Structural equation modeling for identifying the drivers of health-related quality of life improvement experienced by patients with migraine receiving eptinezumab. J Headache Pain 25:45. https:\/\/doi.org\/10.1186\/s10194-024-01752-z","journal-title":"J Headache Pain"},{"key":"12809_CR25","doi-asserted-by":"publisher","first-page":"65","DOI":"10.1186\/s10194-024-01764-9","volume":"25","author":"C Argoff","year":"2024","unstructured":"Argoff C, Herzog SP, Smith RM, Kotak SV, Sopina L, Saltarska Y, Soni-Brahmbhatt S, Khan FA (2024) Real-world effectiveness and satisfaction with intravenous eptinezumab treatment in patients with chronic migraine: REVIEW, an observational, multi-site, US-based study. J Headache Pain 25:65. https:\/\/doi.org\/10.1186\/s10194-024-01764-9","journal-title":"J Headache Pain"},{"key":"12809_CR26","doi-asserted-by":"publisher","first-page":"1533","DOI":"10.1007\/s40120-023-00529-x","volume":"12","author":"AM Blumenfeld","year":"2023","unstructured":"Blumenfeld AM, Lipton RB, Silberstein S, Tepper SJ, Lt C, Landy S, Kuruvilla DE, Manack Adams A (2023) Multimodal migraine management and the pursuit of migraine freedom: a narrative review. Neurol Ther 12:1533\u20131551. https:\/\/doi.org\/10.1007\/s40120-023-00529-x","journal-title":"Neurol Ther"},{"key":"12809_CR27","doi-asserted-by":"publisher","first-page":"1032103","DOI":"10.3389\/fneur.2022.1032103","volume":"13","author":"M Vincent","year":"2022","unstructured":"Vincent M, Viktrup L, Nicholson RA, Ossipov MH, Vargas BB (2022) The not so hidden impact of interictal burden in migraine: a narrative review. Front Neurol 13:1032103. https:\/\/doi.org\/10.3389\/fneur.2022.1032103","journal-title":"Front Neurol"}],"container-title":["Journal of Neurology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00415-024-12809-z.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00415-024-12809-z\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00415-024-12809-z.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,29]],"date-time":"2025-01-29T17:55:48Z","timestamp":1738173348000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00415-024-12809-z"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12,12]]},"references-count":27,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2025,1]]}},"alternative-id":["12809"],"URL":"https:\/\/doi.org\/10.1007\/s00415-024-12809-z","relation":{},"ISSN":["0340-5354","1432-1459"],"issn-type":[{"value":"0340-5354","type":"print"},{"value":"1432-1459","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,12,12]]},"assertion":[{"value":"22 July 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"2 October 2024","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"5 October 2024","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 December 2024","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"SJT reports research funding from AbbVie, Aeon, Amgen, Annovis, Axsome, Cassava, Cognition, Eli Lilly, Inhibikase, Ipsen, Lundbeck, Merz, Neurolief, Pfizer, PrecisionMed, Revance, Scilex, Suven, and UCB. He served as a consultant and\/or on advisory boards (honoraria) from AbbVie, Aeon, Alphasights, Amgen, Aruene\/eNeura, Atheneum, Axsome Therapeutics, Becker Pharmaceutical Consulting, ClearView Healthcare Partners, ClickTherapeutics, CoolTech, CRG, Decision Resources, Defined Health, DRG, Eli Lilly, ExpertConnect, FCB Health, Fenix, GLG, Guidepoint Global, Health Advances, Health Science Communications, HMP Communications, Impel, Initiator Pharma, InteractiveForums, Keyquest, Ki Health Partners, Krog and Partners, Lundbeck, M3 Global Research, Magellan Health, Magnolia Innovation, Miravo Healthcare, MJH Holdings, Neurofront Therapeutics, Neurolief, Nocira, Novartis, P Value Communications, Pain Insights, Palion Medical, Perfood, Pfizer, Pulmatrix, Putnam Associates, Rehaler, SAI MedPartners, Satsuma, Scilex, Slingshot Insights, Spherix Global Insights, Strategy Inc, Synapse Medical Communication, System Analytic, Taylor and Francis, Tegus, Teva, Theranica, Tonix, Trinity Partners, Unity HA, Vial, and XOC. He received salary from Dartmouth-Hitchcock Medical Center, Thomas Jefferson University, and Ki Health Partners. He serves on the speakers' bureau for AbbVie, Eli Lilly, Pfizer, Scilex, and Teva. He received CME honoraria from the American Academy of Neurology, American Headache Society, Annenberg Center for Health Sciences, Catamount Medical Education, Diamond Headache Clinic, Forefront Collaborative, Haymarket Medical Education, HMP Global, Medical Education Speakers Network, Medical Learning Institute Peerview, Migraine Association of Ireland, Miller Medical Education, National Association for Continuing Education, North American Center for CME, The Ohio State University, Physicians\u2019 Education Resource, PlatformQ Education, Primed, Vindico Medical Education, and WebMD\/Medscape. MLD is an advisory board member for Amgen, Assertio, Eli Lilly, Lundbeck, Promius Pharma, Supernus Pharmaceuticals, Teva, and Upsher\u2010Smith Laboratories; a consultant for Amgen, Eli Lilly, Lundbeck, Promius Pharma, and Teva; and speaker's bureau for Amgen, Assertio, Eli Lilly, Supernus Pharmaceuticals, and Teva. DA and DF are full-time employees of Lundbeck LLC. JH is an employee of Pacific Northwest Statistical Consulting, Inc., a company that received funding from Lundbeck LLC for time spent conducting this research. RC was an employee of Lundbeck LLC for the development and conduct of PROMISE-2 and currently consults with Lundbeck and is a part time employee at Axon.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was approved by the independent ethics committee or institutional review board at each study site. All clinical work was conducted in compliance with current good clinical practices, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines, local regulatory requirements, and the principles of the Declaration of Helsinki.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"All patients enrolled in the study provided written informed consent before any study procedures.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate\/publish"}}],"article-number":"4"}}