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Disproportionality analyses, including ROR and IC 025 , quantify reporting patterns relative to background rates and do not measure clinical risk or incidence.Reference Prieto-Merino, Quartey, Wang and Kim 45 Accordingly, an IC 025 value below zero indicates an absence of disproportionality rather than a signal of protection.Reference Prieto-Merino, Quartey, Wang and Kim 45 These metrics are meant to detect safety signals, not infer benefit

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