Among the 2221 patients enrolled in ACROSTUDY, 5567 AEs were reported in 1255 patients (56.5%; Table 4), with the most commonly reported AEs being increased IGF1 (10.4%), headache (5.1%), vitamin D deficiency (4.9%), arthralgia (4.6%), osteoarthritis (3.6%), depression (2.6%), diabetes mellitus (2.3%), cholelithiasis (2.3%), and colonic polyp (2.2%). This evidence concerns the gene IGF1 and cholelithiasis.