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Article History

Received: 24 September 2020

Accepted: 5 January 2021

First Online: 25 January 2021

Ethics approval and consent to participate

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.This study was approved by the New England Institutional Review Board (IRB Study No. 3325). The current study was designed as an analysis based on claims data from a large insured population in the US. There was no active enrollment or active follow-up of study subjects, and no data were collected directly from individuals. The HIPAA Privacy Rule permits PHI in a limited data set to be used or disclosed for research, without individual authorization, if certain criteria are met (further described 45 CFR Part 160 and Subparts A and E of Part 164). Thus informed consent was not required.

: Not applicable.

: DCB, AJA, DHT, and SL are employees of HealthCore, Inc., and were paid consultants to Pfizer in connection with the development of this manuscript. RY was an employee of HealthCore, Inc. at the time of this study, and is now an employee of Anthem Inc. CD is an employee of Pfizer Inc. AS and JHL were paid consultants to HealthCore, Inc. for the assessment of ALI events but received no compensation for authorship. JWF is an independent consultant in drug-induced liver injury for several pharmaceutical companies, none which have drugs in development or on the market in the same class or the same indication.