i. Male: CrCl (mL/min) = (140 - age) × wt (kg) / (serum creatinine × 72); ii. Female: Multiply above result by 0.85; h. UPCR ≤ 1; i. Serum phosphorus, calcium, magnesium and potassium ≥ LLN; j. Prothrombin time (PT)/INR or partial thromboplastin time (PTT) test < 1.3 x the ULN within 7 days before the first dose of study treatment;