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The physician should provide information to the patient about the signs and symptoms of hepatotoxiciy that should cause alarm (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness and "flu-like" symptoms)

This means: No human PK reference data No human bioavailability data No human metabolism or clearance data Rodent-to-human PK extrapolation is therefore speculative This is a major context for research framing