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Authors
McGarvey, November https://orcid.org/0000-0003-4439-4788
Gitlin, Matthew https://orcid.org/0000-0002-9929-4891
Fadli, Ela
Chung, Karen C. https://orcid.org/0000-0003-4170-8390
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Funding
Funding for this research was provided by:
GRAIL, LLC, a subsidiary of Illumina, Inc.
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Article History
Received: 2 March 2022
Accepted: 12 August 2022
First Online: 13 September 2022
Declarations
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: All methods were performed in accordance with the relevant guidelines and regulations. Patient-level data, anonymized and deidentified by Optum prior to sharing with the researchers, were used in the study analyses in compliance with the patient confidentiality requirements of the Health Insurance Portability and Accountability Act of 1996 and all other relevant guidelines and regulations. Administrative permissions to access the anonymized, de-identified data were granted by Optum on October 1, 2020 through a third party agreement. The Western Institutional Review Board (WIRB)-Copernicus Group Institutional Review Board (WCG IRB) determined this research was exempt on December 9, 2021. This ruling of exemption was based on the fact that the analysis relied on secondary retrospective data that was fully deidentified and recorded in a way where the identity of human subjects could not be ascertained directly or indirectly and were thus anonymous. Additionally, the researchers had no contact with data subjects.
: Not applicable.
: MG and NM are employees of BluePath Solutions and EF was an employee of BluePath Solutions at the time of the analysis. BluePath Solutionsreceived funding from GRAIL LLC, a subsidiary of Illumina Inc currently held separate from Illumina Inc under the terms of the Interim Measures Order of the European Commission dated 20 October 2021 for this analysis. KCC is an employee of GRAIL, LLC, who supported this analysis.
