Laboratory abnormalities leading to treatment discontinuation included one event of anemia in one patient (0.1 E/100 PY; not associated with the study drug), and one event each of ALT elevation (0.1 E/100 PY) and AST elevation (0.1 E/100 PY) in the same patient (reasonable possibility of being associated with the study drug). This evidence concerns the gene GPT and anemia (phenotype).