Slade, David
Ray, Riju http://orcid.org/0000-0002-2540-4533
Moretz, Chad http://orcid.org/0000-0003-1828-1667
Germain, Guillaume http://orcid.org/0000-0002-4525-7673
Laliberté, François
Shen, Qin
Duh, Mei Sheng http://orcid.org/0000-0001-5035-6687
Mahendran, Malena
Hahn, Beth http://orcid.org/0000-0002-7396-9336
Funding for this research was provided by:
GlaxoSmithKline
Article History
Received: 24 November 2020
Accepted: 16 July 2021
First Online: 31 July 2021
Declarations
:
: The study was designed and conducted in accordance with the principles of the 1964 Declaration of Helsinki and its later amendments. The study used fully de-identified retrospective claims data, which were compliant with the patient requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and as such was not classified as research involving identifiable private information on human participants under the US Department of Health and Human Services Policy for the Protection of Human Subjects. Therefore, institutional review board approval and informed consent were not required. The de-identified Clinformatics Data Mart database was accessed under an agreement between GSK and Optum, and no further permission was required.
: Not applicable.
: DS, RR, QS and BH are employees of GSK and own stocks/shares in GSK. CM was an employee of GSK at the time of the study. GG, FL, MSD and MM are employees of Analysis Group, Inc., a consulting company that has received research funds from GSK to conduct the study.