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Treatment with EGRIFTA resulted in an increase from baseline in mean lean body mass of 1.3 kg in Study 1 and of 1.2 kg in Study 2, respectively (compared with a decrease of 0.2 kg in Study 1 and of 0.03 kg in Study 2, respectively, in patients receiving placebo)

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Section 1115A(d)(3) of the Act exempts Innovation Center model tests and expansions, which include the MDPP expanded model from the provisions of the PRA