 - Liver abnormalitydisease - Alanine transaminase ALT 2.5x upper limit of normal ULN or ALT5xULN if documented HES with liver manifestations, or bilirubin 1.5xULN isolated bilirubin 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin 35 percent, or current active liver or biliary disease with the exception of Gilberts syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice, or cirrhosis. 