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Claims of treatment benefit should not be made outside approved labeling or an institutional review boardapproved protocol

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Public statements and announcements do not constitute completed regulatory action until formally published by the FDA

Mechanistic investigations have shown that AOD 9604 increases 3-adrenergic receptor expression at the mRNA level, restoring receptor density in systems where lipolytic responsiveness is impaired

Data was statistically analyzed using Friedman test and post hoc Wilcoxon signed rank test with Bonferroni correction

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