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Eli Lilly cannot submit the NDA until enough Phase 3 data is available to demonstrate both efficacy and safety across the intended patient populations

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-Aminoisobutyric acid, a natural non-protein -amino acid, activates the LKB1/AMPK/SIRT1 axis, promotes NF-B p65 phosphorylation and nuclear translocation, delays IB phosphorylation and degradation, alleviates VSMC inflammation, and activates Nrf2 to relieve oxidative stress, collectively inhibiting VSMC proliferation and migration [221]

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