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The datasets generated during and\/or analysed during the current study are available from the corresponding author on reasonable request.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"VigiLyze\u2122: Information on number of reports and quality of reports from the WHO global database of Individual Case Safety Reports were obtained using VigiLyze.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"Conceptualization and design of work: SP. Data acquisition and analysis: SP, NI, VMS, LG, AA, WR, PJ, PP, JLC, GG, MF, MG. Interpretation of data: SP, NI, VMS,WR, JLC, DMSG. Drafting the manuscript: SP, NI. Revision for important intellectual content: SP, NI, VMS, LG, AA, WR, PJ, PP, JLC, DMSG, GG, MF, MG. All authors have read and approved the final version and agree to be accountable for all aspects of the work in ensuring that questions related to accuracy or integrity of any part of the work are appropriately investigated and resolved.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author\u00a0contributions"}}]}}