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Enhanced BBB permeability can be seen as a result of peripheral inflammation, mediated by alterations in the expression of TJs and transporters

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2.4.1.2 Determination of Sample Size Based on 21 subjects completing the trial, Trial 1 was calculated to have an overall combined statistical power of at least 80% of concluding no effect for the four endpoints (i.e

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[2] [5] These combined actions result in improved glycemic control and significant weight reduction