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Description

This key pharmacological activity forms the theoretical foundation for establishing further connections to sustained antidepressant effect

43,44,45,46 Other notable conditions frequently excluded were a history of cancer within 5 years (52%), immunocompromised state (45%), and vascular disease of the lower extremity (42%)

In a briefing document released prior to the panel discussion, the FDAs internal reviewers said that Ocaliva had failed to demonstrate efficacy in one of its confirmatory trials