Table 1 Clinically acceptable laboratory results during screening window

Haemoglobin (Hb) (transfusion to achieve this allowed)

 ≥ 9 g/dL

Neutrophils

 ≥ 1.5 10⁹/L

Platelet count

 ≥ 100 10⁹/L

ALT

 ≤ 2.5 × ULN

Alkaline phosphatase

 ≤ 5 × ULN

Serum Bilirubin (stenting to achieve this allowed)

 ≤ 1.5 × ULN

Creatinine Clearance (Calculated by Cockcroft-Gault criteria)

 ≥ 50 ml/min

International Normalised Ratio (INR)

 < 1.5 unless taking oral anticoagulant (this to be stopped at least 1 week prior to biopsy, at which point this INR limit will then apply)