5. All laboratory values for hematology, clinical chemistry, lipid profile, and urinalysis must be within the normal range ± 10% at the Screening Visit or at Day -1. If the values are not within the normal range, they must be deemed not clinically significant by the Investigator with documented agreement from the medical monitor. Liver transaminase levels (aspartate transaminase [AST] and alanine transaminase [ALT]) and creatine phosphokinase (CPK) levels must be below the upper limit of normal (ULN) + 10%.