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Clinical Evidence Pivotal Studies and Randomized Controlled Trial Evidence Description of Studies Study 023 was a phase III, open-label trial with a 14-week, randomized, double-blind, placebo-controlled period followed by a 52-week, open-label period that aimed to evaluate the efficacy and safety of setmelanotide (1 mg to 3 mg daily by subcutaneous [SC] injection) in patients aged greater than or equal to 6 years with BBS or Alstrm syndrome (AS) and obesity

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