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Article History

Received: 25 January 2022

Accepted: 6 September 2022

First Online: 23 September 2022

Declarations

:

: The WCG Institutional Review Board (IRB), the IRB of record for the lead institution (Reagan-Udall Foundation for the FDA), reviewed the study protocol under the Common Rule and has determined it to be non-human research. Additionally, the IRBs of Harvard Pilgrim Healthcare Institute, HealthPartners Institute and Kaiser-Permanente Washington Health Research Institute have reviewed the study and determined it to be non-human subjects, exempt, and minimal risk, respectively. All procedures performed in studies involving human participants were in accordance with the guidelines and regulations specified in master service agreements with each institution comprising the network, and no further administrative permissions were required to access the data. All data were de-identified by the source institution, and only aggregate data were distributed for analysis and presentation.

: CR-W is an employee of Reagan-Udall which received funding from Pfizer in connection with the development of this manuscript and has an ownership interest in Gilead and has received research grants from AbbVie, Merck, Novartis, and Pfizer. KRP was an employee of Pfizer at the time of this work and has stock/stock options in Pfizer. CNM-W is an employee of CVS Health Clinical Trial Services, an affiliate of CVS Health. AJ-A is an employee of HealthCore, Inc. VN was an employee of and had stock/stock options in Humana Healthcare Research, a wholly owned subsidiary of Humana, Inc. at the time of this work. AH, MTB, and JM are employees of and have stock/stock options in Pfizer. JF and KH are employees and shareholders of Eli Lilly and Company. JSB is a principal investigator on multiple ongoing research grants from Pfizer directly and via IMEDS. MS, TCZ, DSC, ABM, YHN, AC, and PAP declare that they have no competing interests.