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Authors
Metes, Ilinca D.
Xue, Lingshu
Chang, Chung-Chou H.
Huskamp, Haiden A.
Gellad, Walid F.
Lo-Ciganic, Wei-Hsuan
Choudhry, Niteesh K.
Richards-Shubik, Seth
Guclu, Hasan
Donohue, Julie M. https://orcid.org/0000-0003-2418-6017
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Funding
Funding for this research was provided by:
National Heart, Lung, and Blood Institute (R01HL119246-04)
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Article History
Received: 23 August 2018
Accepted: 10 September 2019
First Online: 16 October 2019
Ethics approval and consent to participate
: The University of Pittsburgh IRB reviewed this study (IRB#: PRO12100227) and ruled that since it did not involve any interaction with human subjects, only review of existing data, it did not require formal ethics approval and could be designated as “exempt”. Per the University of Pittsburgh IRB the study met all the necessary criteria for an exemption under section:45 CFR 46.101(b) (4) existing data, documents, or recordsAdditionally, the Centers for Medicare and Medicaid Services (CMS), the Pennsylvania Department of Human Services (PADHS), and Quintile’s IMS granted formal permission to access their databases through separate data use agreements with the University of Pittsburgh.
: Not applicable.
: The authors declare that they have no competing interests.
