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Clinical trials in the SURPASS program have demonstrated that tirzepatide effectively reduces hemoglobin A1C levels by approximately 1.6% to 2.4% on average, with effects varying by baseline A1C, dose, and individual response

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Donaldson et al

Potential risks include allergic reactions, infection, and fluid imbalances, especially for individuals with underlying health conditions professional consultation is essential

We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this final rule with comment period, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule