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El Khoury and Nina Ahmad are employees of Janssen Global Services, LLC. Maureen P. Neary is currently an employee of Sanofi, but was an employee of Janssen Global Services, LLC at the time of manuscript development. Corinne Willame is an employee of Janssen Pharmaceutica NV. Jeroen Geurtsen is an employee of Janssen Vaccines & Prevention BV. Maryaline Catillon, Marjolaine Gauthier-Loiselle, Martin Cloutier, and Alice Qu are employees of Analysis Group, Inc., which has received consultancy fees from Janssen Global Services, LLC for the conduct of this study. Elie Saade reports research grants from Janssen; research grants and speaking and lecture fees and travel reimbursement from Sanofi Pasteur; advisory board relationship and research grants from Pfizer; and research grants from Seqirus.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"This claims-based study was considered exempt from review by an institutional review board under 45 CFR \u00a7 46.104(d)(4) as it involved only the secondary use of data that were de-identified in compliance with the Health Insurance Portability and Accountability Act (HIPAA), specifically, 45 CFR \u00a7 164.514.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}