The most frequently reported treatment-emergent AEs by Medical Dictionary for Regulatory Activities High-Level Terms were musculoskeletal and connective tissue pain and discomfort (12.1%), renal lithiasis (8.1%), upper respiratory tract infections (8.1%), headache (6.1%), and edema (5.1%). Only one subject in the placebo group reported a serious AE (severe pain associated with kidney stone), which required hospitalization.