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The FDA has cited concerns over the lack of large-scale, randomized, placebo-controlled human trials demonstrating its safety and efficacy

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This latter pathway results in the formation of fatty acid ethyl esters and takes place primarily in the liver and pancreas, both of which are highly susceptible to the toxic effects of alcohol

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Oxidative stress assessment by immuno-fluorescence ROS levels were also assessed using the dihydroethidium (DHE) probe, according to previously published protocols [28, 29]