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AGW is an Editorial Board member of\n                      Drug Safety\n                      . AW was not involved in the selection of peer reviewers for the manuscript nor in any of the subsequent editorial decisions. NES reported stock ownership through inheritance in Takeda Pharmaceutical Company, CVS Pharmacy Inc, Edwards Lifesciences, and Baxter International outside the submitted work. SAR has received research support from NIH, FDA, CDC and HRSA. She has received consulting fees for work on advisory committees for several pregnancy registries (i.e., for Pfizer, Axsome Therapeutics, Myovant Sciences, Novo Nordisk, and Harmony Biosciences). GAT, EHZ, GJD have nothing to declare. CL has retired from the US Food and Drug Administration and is a consultant to Glaxo Smith Kline, and Stallergenes Greer.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The authors are not permitted to share the claims data according to the data use licensure.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and materials"}},{"value":"This study was approved by the University of Florida Institutional Review Board (IRB202102291).","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Available upon request.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"All authors (1) made substantial contributions to conception or design of the work, or the acquisition, analysis, or interpretation of data for the work; and (2) drafted the work or revised it critically for important intellectual content; and (3) gave final approval of the version to be published; and (4)\u00a0agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All authors read and approved the final manuscript.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}