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The analysis showed that metabolic surgery significantly reduced major adverse cardiovascular events over 3.9 years of follow-up, with a hazard ratio of 0.61

Direct answer: FDA proposed not to include tirzepatide on the 503B bulks list because FDA did not find a clinical need for outsourcing facilities to compound tirzepatide from bulk substance

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J Clin Endocrinol Metab 103(1):288294

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