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The CCA must stipulate that any non-ASM participant party is considered a downstream recipient for CMS data sharing purposes, and must require the non-ASM participant party to comply with applicable data sharing requirements at proposed § 512.760

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While its safety profile was consistently favorable, the largest Phase IIb trial failed to show statistical significance for weight loss, and commercial development was halted in 2007.[2] Despite this, interest in AOD-9604 has continued in the compounding pharmacy and integrative medicine space, particularly given its safety data, its lack of IGF-1 stimulation, and emerging research around joint health