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7-10 It should be noted that these studies involved patients with an average baseline A1C of 8%, so results may be variable in clinical practice

At 40 mg/mL, those same 10 units deliver 160% of the starting dose, which is well above the recommended initial amount

Regulatory bodies may require a dedicated cardiovascular outcomes trial before or after full approval is granted consistent with the precedent set for other agents in this class though the precise regulatory requirements will be determined by the MHRA and EMA based on the totality of evidence submitted

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Democratic Delegate Rodney Willet said the proposed expanded access came out of the bipartisan rural healthcare summit which agreed the price was worth it

Yang J, Hua Z, Zheng Z, Ma X, Zhu L, Li Y