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Based on the ICH S2 (R1) guidance document (International Council for Harmonisation, 2011) and White et al.(2020) relevant cytotoxicity was postulated at a minimum of 50% reduction in viability, as compared to the respective vehicle control

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The levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in the serum were measured using an automatic biochemical analyzer (BIOBASE, BK-280)

It contains no sugar, no wheat, no yeast, no milk, zero soy derivatives, and is entirely gluten-free