13 7. HANDLING OF MISSING VALUES ................................................................................13 ..................................................................................13 CCI CCI Protocol B7791001 Statistical Analysis Plan PFIZER CONFIDENTIAL Page 37.2. Immune Responses Lower Limit of Quantitation...................................................13 7.3. Pharmacokinetic Concentrations and Parameters ...................................................137.4. Efficacy Data...........................................................................................................14 8. STATISTICAL METHODOLOGY AND STATISTICAL ANALYSES ..........................14 8.1. Statistical Analyses .................................................................................................15 8.1.1. Baseline Evaluations...................................................................................158.1.2. Safety Analysis ...........................................................................................15 8.1.2.1. Analysis of Pr imary Endpoint ...................................................15 8.1.2.2. Analysis of Secondary Safety Endpoints ..................................168.1.2.3. Analysis of other Secondary Endpoints ....................................16 8.1.3. Exploratory (Part A) / Secondary (Part B) Efficacy Analyses ...................18 ..............................19 8.1.5. Pharmacokinetics........................................................................................21 8.1.5.1. Tremelimumab and PF-06801591 Pharmacokinetics ...............21 8.1.6. Tremelimumab and PF-06801591 Immunogenicity...................................23 ..................................................................................................23 9. REFERENCES ..................................................................................................................