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Approved products for these uses are available domestically, which is precisely why the "no effective treatment available in the U.S." criterion does not apply
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Post hoc mediation analysis across SURPASS-1 through SURPASS-5 found that decreases in systolic blood pressure (ranging from 1.3 mmHg to 11.5 mmHg across the tirzepatide doses) were primarily mediated through weight loss [91]
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