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Authors
Blanchette, Christopher M.
Whitmire, Sarah
Oh, Joshua
Noone, Joshua
Howden, Reuben
Ardiles, Thomas
Stone, Glenda A.
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Article History
Received: 1 July 2024
Accepted: 12 November 2024
First Online: 16 November 2024
Declarations
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: <i>Higher healthcare cost and utilization before and after diagnosis of AATD in the United States</i>, is a retrospective claims analysis. A Clinical Trial Number is therefore not applicable in this case. The source data for this analysis was the PharMetrics™ Plus Commercial Database. This database utilizes de-identified, HIPAA compliant data. The use of de-identified, publicly available data does not constitute human subjects research as defined at 45 CFR 46.102. Therefore, this study was exempt from review by an institutional review board/ethics committee.
: All data reported are in the aggregate and impossible to link to individual participants, so individual informed consent was not required.
: Drs. Blanchette, Howden, Oh, Noone, and Ms. Whitmire have each received consultation fees from Grifols, Inc. in the past. Dr. Ardiles is an employee of Grifols Shared Services of North America, a subsidiary of Grifols, Inc. Dr. Stone was an employee of Grifols Inc., at the time the research was conducted. Grifols, Inc. a manufacturer of a marketed therapy for the treatment of AATD, funded this study and preparation of this manuscript.
