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Dr LaCivita was employed by the FDA at the time this research was conducted; she is currently a consultant for GlaxoSmithKline and United BioSource, LLC. No other authors have conflicts of interest to declare.","order":2,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study did not involve human subjects research. As such, IRB review was not required.","order":3,"name":"Ethics","label":"Ethics approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":4,"name":"Ethics","label":"Consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":5,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Data are available upon request from the corresponding author (asarpatwari@hsph.harvard.edu).","order":6,"name":"Ethics","label":"Availability of data and material (data transparency)","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":7,"name":"Ethics","label":"Code availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All authors helped conceive of the study. AS, MMM, SBL, HZ, and BB conducted the analysis. All authors reviewed and interpreted the data. AS, FAT, and ASK wrote the first draft of the manuscript. All authors critically contributed to the manuscript. All authors read and approved the final version. The views expressed in this manuscript are those of the authors and do not necessarily represent those of the US Food and Drug Administration.","order":8,"name":"Ethics","label":"Authors\u2019 contributions","group":{"name":"EthicsHeading","label":"Declarations"}}]}}