Leohr, Jennifer
Dellva, Mary Anne
Coutant, David E.
LaBell, Elizabeth
Heise, Tim
Andersen, Grit
Zijlstra, Eric
Hermanski, Lidia
Nosek, Leszek
Linnebjerg, Helle
Article History
First Online: 29 May 2020
Compliance with Ethical Standards
:
: This study was funded by Eli Lilly and Company.
: Jennifer Leohr, Mary Anne Dellva, David E. Coutant, Elizabeth LaBell and Helle Linnebjerg are employees and shareholders of Eli Lilly and Company. Tim Heise has received consulting fees or honoraria from Mylan and Novo Nordisk. Additionally, research funds to Tim Heise’s institution were received from Adocia, Boehringer Ingelheim, Dance Pharmaceuticals, Eli Lilly and Company, Gan & Lee Pharmaceuticals, Johnson & Johnson, Mars, Medimmune, Mylan, Nordic Bioscience, Novo Nordisk, Pfizer, Poxel, Saniona, Sanofi, Wockhardt and Zealand Pharma. Time Heise, Grit Andersen, Eric Zijlstra, Lidia Hermanski and Leszek Nosek are employees of Profil. Additionally, Eric Ziljstra has received payments for lectures from Eli Lilly and Company, Novo Nordisk, Roche Diabetes Care and Aerami Therapeutics.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (Ethik-Kommission der Ärztekammer Nordrhein, Düsseldorf, Germany) 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.
: Eli Lilly and Company provides access to all individual participant data collected during the trial, after anonymisation, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the USA and the 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, 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.