{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T00:37:51Z","timestamp":1767141471271,"version":"build-2238731810"},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2020,9,17]],"date-time":"2020-09-17T00:00:00Z","timestamp":1600300800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,9,17]],"date-time":"2020-09-17T00:00:00Z","timestamp":1600300800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Qual Life Res"],"published-print":{"date-parts":[[2021,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Migraine can negatively impact patient functioning and quality of life. Here, we report the effects of galcanezumab (GMB), a humanized monoclonal antibody that binds to calcitonin gene-related peptide, on patient-reported outcome (PRO) measures in migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>CGAJ was a Phase III, randomized, open-label study (12-month open-label and 4-month post-treatment follow-up) in patients with episodic or chronic migraine. Patients aged 18\u201365\u00a0years with diagnosis of migraine (\u2265\u20094 migraine headache days per month) as defined by International Classification of Headache Disorders (ICHD)-3 beta guidelines were included in the study. Patients were randomized 1:1 with subcutaneous GMB 120\u00a0mg (with a loading dose of 240\u00a0mg) or GMB 240\u00a0mg given once monthly for 12\u00a0months. Changes from baseline in PRO measures such as Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ) and Migraine Disability Assessment (MIDAS) were assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 135 patients were randomized to each galcanezumab dose group. Mean (SD) baseline MSQ total scores were 53.85 (20.34) [GMB 120\u00a0mg] and 53.69 (18.79) [GMB 240\u00a0mg]. For MIDAS, mean (SD) total scores were 45.77 (42.06) [GMB 120\u00a0mg] and 53.96 (61.24) [GMB 240\u00a0mg]. Within-group mean improvement from baseline on MSQ and MIDAS total scores and all individual item\/domain scores were statistically significant for both GMB dose groups, at all-time points during the treatment phase (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001). For MSQ domain scores, greatest improvement was observed in the Role function-restrictive (RF-R) domain (overall least squares (LS) mean change\u2009\u00b1\u2009SE: 31.55\u2009\u00b1\u20091.20 [GMB 120\u00a0mg] and 33.40\u2009\u00b1\u20091.16 [GMB 240\u00a0mg]). For MIDAS, the overall LS mean change\u2009\u00b1\u2009SE from baseline across the entire 12-month treatment phase in total scores were: \u221233.58\u2009\u00b1\u20092.11 (GMB 120\u00a0mg) and \u221232.67\u2009\u00b1\u20092.04 (GMB 240\u00a0mg).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Galcanezumab was associated with statistically significant changes from baseline in the PRO measures across the entire 12-month treatment period. These results indicate improved health-related quality of life and decreased disability among patients treated with galcanezumab.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s11136-020-02632-0","type":"journal-article","created":{"date-parts":[[2020,9,17]],"date-time":"2020-09-17T13:03:17Z","timestamp":1600347797000},"page":"455-464","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Functional impairment and disability among patients with migraine: evaluation of galcanezumab in a long-term, open-label study"],"prefix":"10.1007","volume":"30","author":[{"given":"Janet H.","family":"Ford","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Virginia L.","family":"Stauffer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"McAllister","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sreelatha","family":"Akkala","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Sexson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David W.","family":"Ayer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shufang","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,9,17]]},"reference":[{"issue":"2","key":"2632_CR1","doi-asserted-by":"publisher","first-page":"230","DOI":"10.1111\/head.12038","volume":"53","author":"KR Merikangas","year":"2013","unstructured":"Merikangas, K. R. (2013). Contributions of epidemiology to our understanding of migraine. Headache, 53(2), 230\u2013246. https:\/\/doi.org\/10.1111\/head.12038.","journal-title":"Headache"},{"key":"2632_CR2","doi-asserted-by":"publisher","first-page":"307","DOI":"10.1016\/j.jns.2016.11.071","volume":"372","author":"YW Woldeamanuel","year":"2017","unstructured":"Woldeamanuel, Y. W., & Cowan, R. P. (2017). Migraine affects 1 in 10 people worldwide featuring recent rise: A systematic review and meta-analysis of community-based studies involving 6 million participants. Journal of the Neurological Sciences, 372, 307\u2013315. https:\/\/doi.org\/10.1016\/j.jns.2016.11.071.","journal-title":"Journal of the Neurological Sciences"},{"issue":"10100","key":"2632_CR3","doi-asserted-by":"publisher","first-page":"1211","DOI":"10.1016\/S0140-6736(17)32154-2","volume":"390","author":"GBD Disease","year":"2017","unstructured":"Disease, G. B. D., Injury, I., & Prevalence, C. (2017). Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990\u20132016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet, 390(10100), 1211\u20131259. https:\/\/doi.org\/10.1016\/S0140-6736(17)32154-2.","journal-title":"Lancet"},{"key":"2632_CR4","first-page":"1","volume":"38","author":"Headache Classification Committee of the International Headache, S","year":"2018","unstructured":"Headache Classification Committee of the International Headache, S. (2018). The International Classification of Headache Disorders, 3rd edition. Cephalalgia, 38, 1\u2013211.","journal-title":"Cephalalgia"},{"key":"2632_CR5","doi-asserted-by":"publisher","first-page":"319","DOI":"10.1177\/0333102417732504","volume":"37","author":"E Ruiz de la Torre","year":"2017","unstructured":"Ruiz de la Torre, E., Martelletti, P., Craven, A., Walsh, D., Evans, S., Dumas, P., et al. (2017). Real-world patient perspective on the burden and impact of migraine. Cephalalgia, 37, 319\u2013374. https:\/\/doi.org\/10.1177\/0333102417732504.","journal-title":"Cephalalgia"},{"issue":"5","key":"2632_CR6","doi-asserted-by":"publisher","first-page":"343","DOI":"10.1212\/01.wnl.0000252808.97649.21","volume":"68","author":"RB Lipton","year":"2007","unstructured":"Lipton, R. B., Bigal, M. E., Diamond, M., Freitag, F., Reed, M. L., Stewart, W. F., et al. (2007). Migraine prevalence, disease burden, and the need for preventive therapy. Neurology, 68(5), 343\u2013349. https:\/\/doi.org\/10.1212\/01.wnl.0000252808.97649.21.","journal-title":"Neurology"},{"issue":"1","key":"2632_CR7","doi-asserted-by":"publisher","first-page":"41","DOI":"10.1186\/s10194-019-0993-0","volume":"20","author":"M Leonardi","year":"2019","unstructured":"Leonardi, M., & Raggi, A. (2019). A narrative review on the burden of migraine: when the burden is the impact on people's life. The Journal of Headache and Pain, 20(1), 41. https:\/\/doi.org\/10.1186\/s10194-019-0993-0.","journal-title":"The Journal of Headache and Pain"},{"issue":"8","key":"2632_CR8","doi-asserted-by":"publisher","first-page":"595","DOI":"10.1007\/s10194-012-0482-1","volume":"13","author":"A Raggi","year":"2012","unstructured":"Raggi, A., Giovannetti, A. M., Quintas, R., D'Amico, D., Cieza, A., Sabariego, C., et al. (2012). A systematic review of the psychosocial difficulties relevant to patients with migraine. The Journal of Headache and Pain, 13(8), 595\u2013606. https:\/\/doi.org\/10.1007\/s10194-012-0482-1.","journal-title":"The Journal of Headache and Pain"},{"issue":"1","key":"2632_CR9","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1111\/head.13456","volume":"59","author":"S American Headache","year":"2019","unstructured":"American Headache, S. (2019). The American Headache Society Position Statement On integrating new migraine treatments into clinical practice. Headache, 59(1), 1\u201318. https:\/\/doi.org\/10.1111\/head.13456.","journal-title":"Headache"},{"issue":"7","key":"2632_CR10","doi-asserted-by":"publisher","first-page":"541","DOI":"10.1111\/j.1533-2500.2012.00530.x","volume":"12","author":"A Berger","year":"2012","unstructured":"Berger, A., Bloudek, L. M., Varon, S. F., & Oster, G. (2012). Adherence with migraine prophylaxis in clinical practice. Pain Practice, 12(7), 541\u2013549. https:\/\/doi.org\/10.1111\/j.1533-2500.2012.00530.x.","journal-title":"Pain Practice"},{"issue":"22","key":"2632_CR11","doi-asserted-by":"publisher","first-page":"1821","DOI":"10.1212\/01.wnl.0000335946.53860.1d","volume":"71","author":"ME Bigal","year":"2008","unstructured":"Bigal, M. E., & Lipton, R. B. (2008). Excessive acute migraine medication use and migraine progression. Neurology, 71(22), 1821\u20131828. https:\/\/doi.org\/10.1212\/01.wnl.0000335946.53860.1d.","journal-title":"Neurology"},{"issue":"4","key":"2632_CR12","doi-asserted-by":"publisher","first-page":"644","DOI":"10.1111\/head.12055","volume":"53","author":"AM Blumenfeld","year":"2013","unstructured":"Blumenfeld, A. M., Bloudek, L. M., Becker, W. J., Buse, D. C., Varon, S. F., Maglinte, G. A., et al. (2013). Patterns of use and reasons for discontinuation of prophylactic medications for episodic migraine and chronic migraine: Results from the Second International Burden of Migraine Study (IBMS-II). Headache, 53(4), 644\u2013655.","journal-title":"Headache"},{"issue":"17","key":"2632_CR13","doi-asserted-by":"publisher","first-page":"1698","DOI":"10.1056\/NEJMc1711803","volume":"377","author":"A Charles","year":"2017","unstructured":"Charles, A. (2017). Migraine. New England Journal of Medicine, 377(17), 1698\u20131699. https:\/\/doi.org\/10.1056\/NEJMc1711803.","journal-title":"New England Journal of Medicine"},{"issue":"1","key":"2632_CR14","doi-asserted-by":"publisher","first-page":"6","DOI":"10.1186\/s10194-018-0955-y","volume":"20","author":"S Sacco","year":"2019","unstructured":"Sacco, S., Bendtsen, L., Ashina, M., Reuter, U., Terwindt, G., Mitsikostas, D. D., et al. (2019). European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. The Journal of Headache and Pain, 20(1), 6. https:\/\/doi.org\/10.1186\/s10194-018-0955-y.","journal-title":"The Journal of Headache and Pain"},{"issue":"4","key":"2632_CR15","doi-asserted-by":"publisher","first-page":"578","DOI":"10.1016\/j.joca.2014.01.009","volume":"22","author":"RJ Benschop","year":"2014","unstructured":"Benschop, R. J., Collins, E. C., Darling, R. J., Allan, B. W., Leung, D., Conner, E. M., et al. (2014). Development of a novel antibody to calcitonin gene-related peptide for the treatment of osteoarthritis-related pain. Osteoarthritis Cartilage, 22(4), 578\u2013585. https:\/\/doi.org\/10.1016\/j.joca.2014.01.009.","journal-title":"Osteoarthritis Cartilage"},{"issue":"16","key":"2632_CR16","doi-asserted-by":"publisher","first-page":"1769","DOI":"10.1007\/s40265-018-1002-7","volume":"78","author":"YN Lamb","year":"2018","unstructured":"Lamb, Y. N. (2018). Galcanezumab: First global approval. Drugs, 78(16), 1769\u20131775. https:\/\/doi.org\/10.1007\/s40265-018-1002-7.","journal-title":"Drugs"},{"issue":"8","key":"2632_CR17","doi-asserted-by":"publisher","first-page":"1442","DOI":"10.1177\/0333102418779543","volume":"38","author":"V Skljarevski","year":"2018","unstructured":"Skljarevski, V., Matharu, M., Millen, B. A., Ossipov, M. H., Kim, B. K., & Yang, J. Y. (2018). Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 phase 3 randomized controlled clinical trial. Cephalalgia, 38(8), 1442\u20131454. https:\/\/doi.org\/10.1177\/0333102418779543.","journal-title":"Cephalalgia"},{"issue":"9","key":"2632_CR18","doi-asserted-by":"publisher","first-page":"1080","DOI":"10.1001\/jamaneurol.2018.1212","volume":"75","author":"VL Stauffer","year":"2018","unstructured":"Stauffer, V. L., Dodick, D. W., Zhang, Q., Carter, J. N., Ailani, J., & Conley, R. R. (2018). Evaluation of galcanezumab for the prevention of episodic migraine: The EVOLVE-1 randomized clinical trial. JAMA Neurology, 75(9), 1080\u20131088. https:\/\/doi.org\/10.1001\/jamaneurol.2018.1212.","journal-title":"JAMA Neurology"},{"key":"2632_CR19","doi-asserted-by":"publisher","first-page":"99","DOI":"10.1111\/head.13549","volume":"56","author":"P McAllister","year":"2019","unstructured":"McAllister, P., Ford, J., Stauffer, V., Sexson, M., & Ayer, D. (2019). Patient Functioning and Disability among Patients with Migraine: Evaluation of Galcanezumab in a Long-Term Open Label Study. Headache: The Journal of Head and Face Pain, 56, 99\u2013100. https:\/\/doi.org\/10.1111\/head.13549.","journal-title":"Headache: The Journal of Head and Face Pain"},{"issue":"5","key":"2632_CR20","doi-asserted-by":"publisher","first-page":"1123","DOI":"10.1007\/s11136-012-0230-7","volume":"22","author":"R Rendas-Baum","year":"2013","unstructured":"Rendas-Baum, R., Bloudek, L. M., Maglinte, G. A., & Varon, S. F. (2013). The psychometric properties of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ) in chronic migraine patients. Quality of Life Research, 22(5), 1123\u20131133. https:\/\/doi.org\/10.1007\/s11136-012-0230-7.","journal-title":"Quality of Life Research"},{"issue":"6 Suppl 1","key":"2632_CR21","doi-asserted-by":"publisher","first-page":"S20","DOI":"10.1212\/wnl.56.suppl_1.s20","volume":"56","author":"WF Stewart","year":"2001","unstructured":"Stewart, W. F., Lipton, R. B., Dowson, A. J., & Sawyer, J. (2001). Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology, 56(6 Suppl 1), S20\u201328. https:\/\/doi.org\/10.1212\/wnl.56.suppl_1.s20.","journal-title":"Neurology"},{"key":"2632_CR22","unstructured":"Protocol I5Q-MC-CGAJ: A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients with Migraine. Clinical trials.gov (2015). https:\/\/clinicaltrials.gov\/ProvidedDocs\/87\/NCT02614287\/Prot_000.pdf. Accessed 09 March 2020."},{"issue":"1","key":"2632_CR23","doi-asserted-by":"publisher","first-page":"188","DOI":"10.1186\/s12883-018-1193-2","volume":"18","author":"A Camporeale","year":"2018","unstructured":"Camporeale, A., Kudrow, D., Sides, R., Wang, S., Van Dycke, A., Selzler, K. J., et al. (2018). A phase 3, long-term, open-label safety study of Galcanezumab in patients with migraine. BMC Neurology, 18(1), 188. https:\/\/doi.org\/10.1186\/s12883-018-1193-2.","journal-title":"BMC Neurology"},{"issue":"9","key":"2632_CR24","doi-asserted-by":"publisher","first-page":"629","DOI":"10.1177\/0333102413485658","volume":"33","author":"Headache Classification Committee of the International Headache, S","year":"2013","unstructured":"Headache Classification Committee of the International Headache, S. (2013). The international classification of headache disorders, 3rd edition (beta version). Cephalalgia, 33(9), 629\u2013808. https:\/\/doi.org\/10.1177\/0333102413485658.","journal-title":"Cephalalgia"},{"issue":"6","key":"2632_CR25","doi-asserted-by":"publisher","first-page":"707","DOI":"10.2165\/00019053-199813060-00007","volume":"13","author":"P Jhingran","year":"1998","unstructured":"Jhingran, P., Davis, S. M., LaVange, L. M., Miller, D. W., & Helms, R. W. (1998). MSQ: Migraine-Specific Quality-of-Life Questionnaire. Further investigation of the factor structure. Pharmacoeconomics, 13(6), 707\u2013717. https:\/\/doi.org\/10.2165\/00019053-199813060-00007.","journal-title":"Pharmacoeconomics"},{"issue":"9","key":"2632_CR26","doi-asserted-by":"publisher","first-page":"854","DOI":"10.1046\/j.1526-4610.2001.01156.x","volume":"41","author":"RB Lipton","year":"2001","unstructured":"Lipton, R. B., Stewart, W. F., Sawyer, J., & Edmeads, J. G. (2001). Clinical utility of an instrument assessing migraine disability: The Migraine Disability Assessment (MIDAS) questionnaire. Headache, 41(9), 854\u2013861.","journal-title":"Headache"},{"key":"2632_CR27","doi-asserted-by":"publisher","unstructured":"Stewart, W. F., Lipton, R. B., Kolodner, K., Liberman, J., & Sawyer, J. (1999). Reliability of the migraine disability assessment score in a population-based sample of headache sufferers. Cephalalgia, 19(2), 107\u2013114; discussion 174. https:\/\/doi.org\/10.1046\/j.1468-2982.1999.019002107.x.","DOI":"10.1046\/j.1468-2982.1999.019002107.x"},{"issue":"24","key":"2632_CR28","doi-asserted-by":"publisher","first-page":"e2211","DOI":"10.1212\/WNL.0000000000006640","volume":"91","author":"HC Detke","year":"2018","unstructured":"Detke, H. C., Goadsby, P. J., Wang, S., Friedman, D. I., Selzler, K. J., & Aurora, S. K. (2018). Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology, 91(24), e2211\u2013e2221. https:\/\/doi.org\/10.1212\/WNL.0000000000006640.","journal-title":"Neurology"},{"issue":"6","key":"2632_CR29","doi-asserted-by":"publisher","first-page":"834","DOI":"10.1111\/head.13508","volume":"59","author":"VL Stauffer","year":"2019","unstructured":"Stauffer, V. L., Wang, S., Voulgaropoulos, M., Skljarevski, V., Kovacik, A., & Aurora, S. K. (2019). Effect of galcanezumab following treatment cessation in patients with migraine: results from 2 randomized phase 3 trials. Headache, 59(6), 834\u2013847. https:\/\/doi.org\/10.1111\/head.13508.","journal-title":"Headache"},{"issue":"12","key":"2632_CR30","doi-asserted-by":"publisher","first-page":"1237","DOI":"10.1212\/WNL.0000000000004391","volume":"89","author":"M Ashina","year":"2017","unstructured":"Ashina, M., Dodick, D., Goadsby, P. J., Reuter, U., Silberstein, S., Zhang, F., et al. (2017). Erenumab (AMG 334) in episodic migraine: Interim analysis of an ongoing open-label study. Neurology, 89(12), 1237\u20131243. https:\/\/doi.org\/10.1212\/WNL.0000000000004391.","journal-title":"Neurology"},{"issue":"1","key":"2632_CR31","doi-asserted-by":"publisher","first-page":"13","DOI":"10.1186\/s10194-018-0840-8","volume":"19","author":"AM Blumenfeld","year":"2018","unstructured":"Blumenfeld, A. M., Stark, R. J., Freeman, M. C., Orejudos, A., & Manack Adams, A. (2018). Long-term study of the efficacy and safety of Onabotulinumtoxin A for the prevention of chronic migraine: COMPEL study. The Journal of Headache and Pain, 19(1), 13. https:\/\/doi.org\/10.1186\/s10194-018-0840-8.","journal-title":"The Journal of Headache and Pain"}],"updated-by":[{"DOI":"10.1007\/s11136-020-02720-1","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2020,12,18]],"date-time":"2020-12-18T00:00:00Z","timestamp":1608249600000}}],"container-title":["Quality of Life Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11136-020-02632-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s11136-020-02632-0\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11136-020-02632-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,9,16]],"date-time":"2021-09-16T21:58:08Z","timestamp":1631829488000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s11136-020-02632-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,9,17]]},"references-count":31,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2021,2]]}},"alternative-id":["2632"],"URL":"https:\/\/doi.org\/10.1007\/s11136-020-02632-0","relation":{},"ISSN":["0962-9343","1573-2649"],"issn-type":[{"value":"0962-9343","type":"print"},{"value":"1573-2649","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,9,17]]},"assertion":[{"value":"4 September 2020","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 September 2020","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"16 February 2021","order":3,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Correction","order":4,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"A Correction to this paper has been published:","order":5,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"https:\/\/doi.org\/10.1007\/s11136-020-02720-1","URL":"https:\/\/doi.org\/10.1007\/s11136-020-02720-1","order":6,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with ethical standards"}},{"value":"Janet Ford, Virginia Stauffer, Matthew Sexson, David Ayer, Shufang Wang are employees of Eli Lilly and Company, Indianapolis, IN, USA and hold company stock. Peter McAllister is an employee of New England Institute for Neurology and Headache, USA. He is an independent contractor and part of speaker bureaus at Teva Pharmaceuticals, Amgen and Allergan. Sreelatha Akkala is a full-time employee of Eli Lilly Services India Pvt. Ltd, India.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Each participant provided consent for de-identified and aggregated reporting of research findings.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"This study was performed in full accordance with the US Health Insurance Portability and Accountability Act 1996.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}