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The results presented in this paper have not been published previously in whole or part.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest\/Competing interests"}},{"value":"Ethics committee approval was not required for this observational study because the analysis was carried out on an anonymized pharmacovigilance database.","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":"The datasets generated during and\/or analyzed during the current study are not publicly available because data are owned by UMC, which manages VigiBase\u00ae, but are available from the corresponding author on reasonable request.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"Research idea and study design: AOG, DM, AS, MDD; data acquisition: AOG, DM; data analysis\/interpretation: AOG, DM, AD, ML, AC, TC; statistical analysis: AOG, DM; supervision or mentorship: TC, AS, MDD.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}