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Study schema. The Safety Evaluation Committee (SEC) examined adverse-event reports from completed stages where indicated before subjects were vaccinated in later stages. For stages IIB and IIIB, randomization was stratified by high versus low titers of neutralizing antibodies against Ad5 (≤200 versus >200) and by high versus low titers of neutralizing antibodies against Ad6 (≤18 versus >18) at baseline (1).
