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However, all authors affiliated with pharmaceutical companies are employees and, in some cases, stockholders of the companies. The views expressed in this article represent the authors' thoughts and are independent of their employers.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"This declaration is not applicable as no human participants were involved and no protected\/personal health information (PHI) was used. The data used for this study were metadata related to case transmissions, not safety case data itself.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"TransCelerate ensured collection, anonymization, and aggregation of member company safety data transmissions were performed and coordinated by a third-party project manager. The resulting datasets will remain confidential. Please see Electronic Supplementary Material for more information regarding data collection.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material (data transparency)"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"All authors contributed to the article's conception and design. All authors read and approved the final manuscript. Collection, anonymization, and aggregation of safety data were performed and coordinated by a third party project manager.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}