Chen, Jieling
Borra, Sujana
Huang, Ahong
Fan, Ludi
Pollom, Roy Daniel
Hood, Robert C.
Funding for this research was provided by:
Eli Lilly and Company
Article History
Received: 5 October 2021
Accepted: 21 January 2022
First Online: 21 February 2022
Acknowledgements
:
: Sponsorship for this study and Rapid Service Fee were funded by Eli Lilly and Company.
: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
: All authors were involved in the conception, design, analysis, and interpretation of the data, as well as the drafting and revision of the paper. All authors have approved the final version for publication and accept responsibility for all aspects of the work.
: The authors wish to acknowledge Ishveen Chopra for analytical assistance, and Michael Kane for medical writing assistance, all in the employ of STATinMED Research and funded by Eli Lilly and Company.
: J. Chen. L Fan, and R. Pollom are employees of Eli Lilly and Company, Indianapolis, IN. S. Borra is an employee of SIMR, LLC, Plano, TX—a paid consultant to Eli Lilly and Company, and acted as such in the conduct of this study and manuscript development. At the time of this study, A. Hong was an employee of SIMR, LLC, Plano, TX. R. Hood has received remuneration from Eli Lilly and Company, Indianapolis, IN. for consultation services and as part of their speaker bureau and also has received honoraria from Novo Nordisk, Plainsboro, NJ, as part of their speaker’s bureau.
: Since this study did not involve the collection, use, or transmittal of individually identifiable data, it was deemed exempt from institutional review board (IRB) review. Both the datasets and the security of the offices where analysis was completed (and where the datasets are kept) meet the requirements of the Health Insurance Portability and Accountability Act of 1996. Solutions IRB determined this study to be EXEMPT from the Office for Human Research Protections (OHRP)’s Regulations for the Protection of Human Subjects (45 CFR 46) under Exemption 4: Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. The HIPAA Authorization Waiver was granted in accordance with the specifications of 45 CFR 164.512(i).
: The dataset supporting the conclusions in this article is available from the United States Department of Veterans Affairs. However, restrictions apply to the availability of these data, which were used under license for this study and are not publicly available.