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PMID 19118377

For the primary composite outcome and secondary hierarchical outcomes, the threshold for two-sided statistical significance was set to 0.0322 (one-sided level 0.00161) using Lan-DeMets alpha spending function, which allows to adjust significance levels as data were reviewed for the interim analysis, reducing the chance of false positive results

Adipocyte hypertrophy is considered a key event in insulin resistance in individuals with obesity and MetS, as it increases the levels of proinflammatory cytokines and leads to leptin resistance

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