Studies 437 and 438 Integrated 0-48 WeeksALT Elevations > 10 x ULN

PLB ADV 10

(n=228) (n=294)

ALT > 10 x ULN 17% 6%

ALT > 10 x ULN with:

Bilirubin ? 2.5 mg/dL and 2% 0%

? 1mg/dL above baseline

Albumin < 3 g/dL 1% 0%

PT prolonged ? 1.5 sec ə% 0%

above ULN

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