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Lundbeck & Mertz, received by the universities where he has been employed. He has personally received fees from Atrium Education, the Danish Pharmaceutical Industry Association, for teaching and leading pharmacoepidemiology courses.\u00a0Maurizio Sessa has no conflicts of interest to declare.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"No ethical approval is required for descriptive studies using publicly available data from FAERS.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"The datasets generated during and\/or analyzed during the current study are available from the corresponding author on reasonable request.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Code is available from the corresponding author on reasonable request.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}