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Authors
Kiaii, Bob
Johnston, Stephen S. https://orcid.org/0000-0002-8444-0286
Jang, Se Ryeong
Elangovanraaj, Nivesh
Tewari, Pranjal
Chen, Brian Po-Han
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Funding
Funding for this research was provided by:
Ethicon
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Article History
Received: 9 February 2022
Accepted: 16 August 2022
First Online: 28 August 2022
Declarations
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: We conducted this protocol-driven, retrospective cohort study under the exemption from Institutional Review Board oversight for US-based studies using de-identified healthcare records, as dictated by Title 45 Code of Federal Regulations (45 CFR 46.101(b)(4)). With the exception of the post-hoc analyses, all study analyses and methods were pre-specified within the protocol. Due to the de-identified and retrospective nature of this study, informed consent was not applicable.
: Not applicable.
: BK, Consultant to Johnson & Johnson, Medtronic, Abbott and Boston Scientific; SSJ, Employee and Stockholder, Johnson & Johnson; SRJ, Contract Employee, Johnson & Johnson; NE, Employee, Mu Sigma (Consultant company to Johnson & Johnson), PT, Employee, Mu Sigma (Consultant company to Johnson & Johnson); BPHC, Employee and Stockholder, Johnson & Johnson.
