{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T02:41:06Z","timestamp":1783651266786,"version":"3.55.0"},"reference-count":12,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2021,8,18]],"date-time":"2021-08-18T00:00:00Z","timestamp":1629244800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2022,1]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>In four large controlled trials with lasmiditan and ubrogepant placebo was administered in the first step to demonstrate an effect on migraine attack. In the same trials the investigators also asked the question: is a second dose of the drug effective in non-responders to the first dose? In this phase patients who received placebo in the first phase of the trial again after 2 hours received another dose of placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>To be ethical, clinical research requires balancing rigorous science with the protection of human subjects; and it is, in our view, questionable whether placebo was used with \u201cscientific rigor\u201d in the second step of these trials, and this design is not recommended.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03331024211029939","type":"journal-article","created":{"date-parts":[[2021,8,19]],"date-time":"2021-08-19T02:19:11Z","timestamp":1629339551000},"page":"82-85","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Doubtful use of placebo following placebo in recent controlled trials of lasmiditan and ubrogepant for the treatment of migraine attacks"],"prefix":"10.1177","volume":"42","author":[{"given":"Peer","family":"Tfelt-Hansen","sequence":"first","affiliation":[{"name":"Danish Headache Center, Department of Neurology, Rigshospitalet -Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karsten","family":"J\u00f8rgensen","sequence":"additional","affiliation":[{"name":"Centre for Evidence-Based Medicine Odense (CEBMO) and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Denmark"},{"name":"Open Patient data Exploratory Network (OPEN), Odense University Hospital, Odense, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6556-8612","authenticated-orcid":false,"given":"Hans-Christoph","family":"Diener","sequence":"additional","affiliation":[{"name":"Institute Medical Informatics, Biometry and Epidemiology, Medical Faculty of the University Duisburg-Essen, Essen, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2021,8,18]]},"reference":[{"key":"bibr1-03331024211029939","doi-asserted-by":"publisher","DOI":"10.1111\/head.12823"},{"key":"bibr2-03331024211029939","doi-asserted-by":"publisher","DOI":"10.1046\/j.1468-2982.1994.1405330.x"},{"key":"bibr3-03331024211029939","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp.62.5.490"},{"key":"bibr4-03331024211029939","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000006641"},{"key":"bibr5-03331024211029939","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/awz134"},{"key":"bibr6-03331024211029939","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1813049"},{"key":"bibr7-03331024211029939","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2019.16711"},{"key":"bibr8-03331024211029939","doi-asserted-by":"publisher","DOI":"10.1186\/s12883-019-1420-5"},{"key":"bibr9-03331024211029939","first-page":"98","volume":"59","author":"Ailani J","year":"2019","journal-title":"Headache"},{"key":"bibr10-03331024211029939","doi-asserted-by":"publisher","DOI":"10.1177\/0333102419828967"},{"key":"bibr11-03331024211029939","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2013.09.003"},{"key":"bibr12-03331024211029939","doi-asserted-by":"publisher","DOI":"10.1185\/03007999909116496"}],"container-title":["Cephalalgia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03331024211029939","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/03331024211029939","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03331024211029939","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T14:49:10Z","timestamp":1777387750000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/03331024211029939"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,8,18]]},"references-count":12,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2022,1]]}},"alternative-id":["10.1177\/03331024211029939"],"URL":"https:\/\/doi.org\/10.1177\/03331024211029939","relation":{},"ISSN":["0333-1024","1468-2982"],"issn-type":[{"value":"0333-1024","type":"print"},{"value":"1468-2982","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,8,18]]}}}