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Separate-Vial Reconstitution Reconstitution math for 10 mg standalone vials Vial CJC-1295 10 mg BAC water 3.0 mL Concentration 3.33 mg/mL 200 mcg dose 6 units (0.06 mL) Vial Ipamorelin 10 mg BAC water 3.0 mL Concentration 3.33 mg/mL 200 mcg dose 6 units (0.06 mL) This separate-vial reference uses 3.0 mL as the maximum fill for the same vial-capacity constraint

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In any patient with spontaneous hematoma and purpura, in the context of nutritional disorder, scurvy should be systematically considered

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However, we note that this was based on comparing two separate phase 3 trials, which can involve numerous confounding variables, and the applicant did not provide support related to clinical trial design or statistical analysis to explain why the potential effect of confounding variables should not be a concern for purposes of this comparison