7. HANDLING OF MISSING VALUES All the safety, immune responses, pharmacokinetic, pharmacodynamics, and immunogenicity analyses and summaries will be based on data as observed and no explicit imputation will be applied. 7.2. Immune Responses Lower Limit of Quantitation Titers below the assay detection limit will be assigned a value of one-half that limit. 7.3. Pharmacokinetic Concentrations and Parameters Drug concentrations below the limit of quantification In all data presentations (except listings), drug concentrations below the limit of quantification (BLQ) will be set to zero. In the listings BLQ values will be reported as “<LLQ”, where LLQ will be replaced with the value for the lower limit of quantification.CCI CCI Protocol B7791001 Statistical Analysis Plan PFIZER CONFIDENTIAL Page 14Deviations, missing concentrations and anomalous values Patients who experience eve nts that may affect their PK (eg, incomplete dosing) may be excluded from the PK analy sis. In summary tables and plots of mean profiles of PK, statistics will be calculated having set concentrations to missing if 1 of the following cases is true: 1.A concent ration has been collected as ND (ie, not done) or NS (ie, no sample); 2. A deviation in sampling time is of sufficient concern or a concentration has been flagged anomalous b y the PK anal yst. Note that summary statistics will not be presented at a particular time point if more than 50% of the data are missing. An anomalous concentration value is one that, after verification of bioanal ytical validity , is grossl y inconsistent with other concentration data from the same individual or from other patients. For exa mple, a BLQ concentration that is between quantifiable values from the same dose is considered as anomalous. Anomalous concentration values may be excluded from PK anal ysis at the discretion of the PK anal yst. Pharmacokinetic parameters Actual PK sampling times will be used in the derivation of PK parameters. If a PK parameter cannot be derived from a patient’s concentration data, the parameter will be coded as NC (ie not calculated). In summary tables, statistics will be calculated b y setting NC values t o missing; and statistics will not be presented for a particular treatment if more than 50% of the data are NC. For statistical analy ses (ie analy sis of variance), PK parameters coded as NC will also be set to missing . 7.4.Efficacy Data For the time-to-event endpoints, the missing data handling method will be censoring. Censoring rules for time -to-event endpoints are detailed in Appendix 10.3. 8. STATISTICAL METHODOL OGY AND STATISTICAL ANALYSES In general, all continuous endp oints will be summarized descriptive lyby cohort. If data are categorical then the standard contingency tables with counts and percent by group will be display ed. Protocol B7791001 Statistical Analysis Plan PFIZER CONFIDENTIAL Page 158.1.