- Clinically significant abnormal laboratory values(eg. Routine blood value above or below 1.2 times of the normal range; urine WBC, RBC or protein ≥++; ALT or AST value above 1.5 times of clinical top-limit; BUN value above 1.2 times of top-limit; Cr value above normal top-limit; thyroid gland function index above or below 1.2 times of the normal range, Fasting plasma glucose value above 1.2 times of normal top-limit; blood fat value above 1.5 times of normal top-limit).