- Adequate organ functions: normal bone marrow function (Hb ≥6.0 mmol/L, absolute neutrophil count ≥1.5 x 109/L, platelet count ≥100 x 109/L), renal function (serum creatinine ≤1.5 x ULN and creatinine clearance [Cockroft formula] ≥30 ml/min), determined <3 months prior to randomisation;