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Abbreviations AEs: Adverse events NAEs: Neurological adverse events FDA: The Food and Drug Administration FAERS: The FDA Adverse Event Reporting System GLP-1 RAs: Glucagon-like peptide-1 receptor agonists ADRs: Adverse drug reactions PTs: Preferred Terms SOCs: System Organ Classes IQR: Interquartile range ROR: Reporting odds ratio CI: Confidence interval PRR: Proportional reporting ratio BCPNN: Bayesian Confidence Propagation Neural Network EBGM: Empirical Bayesian geometric mean EBGM05: The lower limit of 95% CI of EBGM IC: Information component IC025: The lower limit of 95% CI of the IC VANs: Vagal afferent neurons T2DM: Type 2 diabetes mellitus OR: Odds ratios References Targher, G., Mantovani, A

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Instead, the 503A is limited to dispensing the 503B product only pursuant to a valid prescription directly to the identified individual patient