FAS and nutritional disorder: The most commonly occurring AEs include metabolic and nutritional disorders, endocrine disorders, renal and urinary disorders, and GI disorders, which showed the incidence rates per 100 person-days of 0.6 (0.2, 1.5), 0.6 (0.2, 1.5), 0.3 (0.1, 1.1), and 0.3 (0.1, 1.1), respectively in the FAS-P1 population.