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A device is substantially equivalent if, in comparison to the predicate if it: has the same intended use

AOD9604 had no significant effect in the 3-KO mice

It can improve A1C levels as well as lead to weight loss up to 15% in a little over a year

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In the multivariate analysis, l-carnitine administration (odds ratio [OR] 3.51, 95% confidence interval [CI] 1.239.99, p = 0.019) and baseline NIRS data of 0.07 mMmm (OR 5.21, 95% CI 1.6916.0, p = 0.0041) were found as independent significant factors