INTERIM ANALYSES, FINAL ANALYSES AND UNBLINDING There are no formal interim analyses planned in this study. However, this is an open label study, and therefore, the Pfizer team will review safety, immunogenicity, pharmacokinetics, pharmacodynamic, and other data throughout the study.CCI CCI Protocol B7791001 Statistical Analysis Plan PFIZER CONFIDENTIAL Page 84.HYPOTHESES , SAMPLE SIZE AND DECISION RULES 4.1.Statistical Hypotheses No formal testing of h ypotheses will be conducted in this study . 4.2.Statistical Dec ision Rules The following table shows the probability of escalating to the next dose level for a range of underlying true dose limiting toxicity (DLT)rates.