 13. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases e.g., severe hepatic impairment, interstitial lung disease bilateral, diffuse, parenchymal lung disease, uncontrolled chronic renal diseases glomerulonephritis, nephritic syndrome, Fanconi Syndrome or Renal tubular acidosis, serious active infection or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension blood pressure 14090, active bleeding diatheses or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions and infectious diseases is not required. 