Two-sided P values of significantly less than 0.05 were considered to indicate statistical significance. SAS software program, edition 9.2 was used for analyses. An independent statistician conducted one planned interim analysis for efficacy after 50 percent of the infants had been enrolled; an external protection and data monitoring committee reviewed the analysis.001. The external data and security monitoring committee reviewed safety data four times.Copyright 2009 Advisory Board Organization and Kaiser Family Basis. All rights reserved.
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