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Dosing & Reconstitution Guide Educational guide for reconstitution and daily dosing Standard / Gradual Approach (3 mL = ~6.67 mg/mL total) Route: Subcutaneous injection | Frequency: Once daily For 10-unit (0.10 mL) administrations during Weeks 14, consider using 30- or 50-unit insulin syringes for improved readability

However, such episodes would not be appropriate for ASM because the conditions covered must have an associated MIPS EBCM

et al., Nature Medicine 3

As further discussed in this section, we proposed to align some data submission requirements under this model with the data submission requirements under MIPS as defined at 414.1325