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Shelf Life:18 Months

Visceral hypersensitivity, serotonin dysregulation, gut-brain axis dysfunction, and central/peripheral nervous system alterations are implicated in IBS-C pain, while FC pain is less studied and may be primarily linked to colonic distension and motility dysfunction

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Determines expedited reporting timelines Critical for SUSAR identification in clinical trials Supports signal detection Impacts regulatory submissions (e.g., expedited ICSRs) Pro Tip for PV Professionals: Expectedness assessment must always be performed against the current version of the Reference Safety Information (RSI)- not outdated labeling