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AKS-452 Phase II clinical study design. Phase II was a 2 × 26 design; i.e., Cohort 1 was a single-dose (90 µg) and Cohort 2 was a two-dose (45 µg) regimen in which subjects were enrolled and dosed concurrently. The dosing regimens were based on safety and immunogenicity outcomes of the interim results of the phase I study [15].
