When the double-blind and open-label treatment-extension phases were combined, the most frequently reported AEs were increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), and upper respiratory tract infection (each 21.4 %), as well as bronchitis, nasopharyngitis, dizziness, and increased lactate dehydrogenase (each 14.3 %). This evidence concerns the gene GPT and bronchial disorder.