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The FDA's analysis of pooled safety data from tirzepatide clinical trials identified acute pancreatitis cases but noted that many patients who developed pancreatitis had identifiable alternative risk factors, including gallstones, alcohol use, or hypertriglyceridemia

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The initial forestomach lesions in rodents were attributed to the irritant action of chlorothalonil, and, where this does not occur, a NOEL can be attained