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The FDAs Center for Drug Evaluation and Research (CDER) issued the warning letter after finding issues with how the company reported adverse drug experiences from real patients
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It was a 72-week, double-blind, randomized, placebo-controlled phase 3 trial enrolling 2,539 adults with obesity, or with overweight and at least one weight-related comorbidity, and excluding those with type 2 diabetes
Neumiller JJ, Sonnett TE, Wood LD, et al
Besides removing free radicals, glutathione plays a role in making DNA, forming sperm cells, and removing toxic mercury from the brain
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Although tirzepatide did not ameliorate the memory deficits or antioxidant reductions caused by cisplatin, it did lead to a reduction in ROS and MDA levels
