Linnebjerg, Helle
Zhang, Qianyi
LaBell, Elizabeth
Dellva, Mary Anne
Coutant, David E.
Hövelmann, Ulrike
Plum-Mörschel, Leona
Herbrand, Theresa
Leohr, Jennifer
Funding for this research was provided by:
Eli Lilly and Company
Article History
First Online: 29 May 2020
Compliance with Ethical Standards
:
: This study was funded by Eli Lilly and Company.
: Helle Linnebjerg, Qianyi Zhang, Elizabeth LaBell, Mary Anne Dellva, David E. Coutant, and Jennifer Leohr are employees and shareholders of Eli Lilly and Company. Ulrike Hövelmann, Leona Plum-Mörschel, and Theresa Herbrand are employees of Profil.
: Eli Lilly and Company 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 United States and European Union 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, 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.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (Medical Council North Rhine, Düsseldorf, Germany, 2017020) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.