Benefits of the phase III study.

The vaccine was well tolerated generally, and the most frequent adverse event reported in the trial was regional discomfort at the injection site. The study is part of a continuing phase III plan involving a lot more than 25,000 people in 33 countries. For future years II study, a prospective, randomized, double-blind, placebo-controlled study, ladies aged 16 to 26 years were randomized to receive a three-dose program of either the vaccine or placebo at Time 1, Month 2, and Month 6. The analyses evaluated the incidence of cervical pre-cancers through follow up for an average of 20 months after completion of the regimen.All the authors examined and provided opinions on all versions of the manuscript and produced the final decision to send it for publication. All of the authors assume responsibility for the completeness and accuracy of the data and analyses provided and for the fidelity of the analysis to the protocol, available at NEJM.org. Efficacy Assessments HCV genotype and subtype were evaluated from plasma samples with the use of the Versant HCV Genotype Inno-LiPA Assay, version 2.0 .0 , with a lesser limit of detection of 15 IU per milliliter and a lower limit of quantification of 25 IU per milliliter. Information on the collection of plasma samples, protocol-specified criteria for virologic failure, and level of resistance testing are given in the Supplementary Appendix.