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This language is misleading because compounded drugs are not reviewed for safety and efficacy by the FDA and, unlike approved drugs, are not necessarily produced in facilities subject to Current Good Manufacturer Practice (CGMP) regulations

The exclusion criteria were as follows: (1) any previous lower limb pathology, such as infections, stress fracture, surgery, or musculoskeletal injury, and (2) any treatment for PFis or other treatments for the ankle/foot