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Benefits Exceptional weight loss: Patients with obesity (without diabetes) lost an average of 2224% of body weight at 48 weeks on 812 mg doses [3] [4]
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Protective benefits are evidenced in the liver, GI tract, cardiovascular system, and nervous system [6, 11, 25]
(1996) Transport and metabolism of glutathione conjugates of menadione and ethacrynic acid in confluent monolayers of rat proximal tubular cells Toxicology 112, 117-130 8
And so FDA is going to need to use a different lens. Unlike FDA approval of a new drug, which requires years of clinical trials demonstrating safety and effectiveness, placement on the 503A Bulks List answers a different regulatory question