Doty, Erin G. http://orcid.org/0000-0003-1400-4427
Hauck, Paula M.
Krege, John H.
Komori, Mika
Hake, Ann M.
Dong, Yan
Lipton, Richard B.
Funding for this research was provided by:
Eli Lilly and Company
Article History
Accepted: 16 May 2022
First Online: 2 July 2022
Declarations
:
: This study and its open access publication was sponsored/funded/supported by Eli Lilly and Company.
: RBL receives research support from the NIH, FDA, as well as the National Headache Foundation and the Marx Foundation. He also receives research support from Allergan/Abbvie, Amgen, Eli Lilly, and Electrocore. He receives personal fees as a consultant or advisor from Allergan/Abbvie, Amgen, Biohaven Holdings, Dr. Reddy's, GlaxoSmithKline, Grifols, Impel NeuroPharma, Eli Lilly, Lundbeck, Merck, Novartis, and Teva Pharmaceuticals. He holds stock or options in Biohaven Holdings, CtrlM Health and Manistee. EGD, PMH, JHK, MK, AMH, and YD are employees and minor stockholders of Eli Lilly and Company.
: The studies were carried out in accordance with the International Conference on Harmonisation Good Clinical Practice guidelines, and local regulatory requirements. The protocols were approved by an institutional review board or independent ethics committee at each study site.
: Written informed consent for study participation was obtained from each patient prior to the start of the study.
: Not applicable.
: Not applicable.
: AMH, EGD, JHK, PMH, and RBL, were involved in study conception and design. MK acquired data. EGD, PMH, and YD performed data analysis. EGD, JHK, MK, PMH, RBL, and YD, provided data interpretation. AMH, EGD, JHK, MK, PMH, RBL, and YD, were involved in drafting/revising the article. AMH, EGD, JHK, MK, PMH, RBL, and YD, have read and provided approval of the final submitted version of the manuscript and agree to be accountable for the presented work.
: Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, and blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at ExternalRef removed.