- Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Umol/L Or Creatinine Clearance < 45 Ml/Min, Aspartate transaminase (AST) > 2 Times Above The Normal Range, Alanine transaminase (ALT) > 2 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L