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[email protected] International: 1-307-885-4724 US (Toll Free): 877-885-4724. Se Habla Español WebHowever, if a serious and unexpected adverse event occurs for which there is evidence suggesting a causal relationship between the drug and the event (e.g., death from anaphylaxis), the event must be reported under § 312.32 (c) (1) (i) as a serious and unexpected suspected adverse reaction even if it is a component of the study endpoint …
C ind
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