193 6.4.1.4. Assessment of Severity .......................................................................... 195 6.4.1.5. Assessment of Causality ........................................................................ 196 6.4.1.6. Exceptions ............................................................................................. 197 6.4.1.7. Follow-Up of Patients Reporting Adverse Events ................................ 197 6.4.1.8. Events of Clinical Interest ..................................................................... 198 6.5. Safety Monitoring Committee .............................................................................. 199 6.6. Pregnancy in Partners of Male Patients ................................................................ 199 6.7. Laboratory Analyses ............................................................................................. 199 6.8. Tumor Imaging and Assessment of Disease ......................................................... 201 6.8.1. Initial Tumor Imaging ........................................................................... 202 6.8.2. Tumor Imaging During the Study ......................................................... 203 6.8.3. End of Treatment and Follow-up Tumor Imaging ................................ 203 6.8.4. RECIST 1.1 Assessment of Disease ...................................................... 204 6.8.5. iRECIST Assessment of Disease ........................................................... 204 7. Statistical and Analytical Plan ....................................................................................... 209 7.1. Primary Efficacy Endpoints .................................................................................. 209 7.2. Secondary Efficacy Endpoints .............................................................................. 209 7.3. Exploratory Endpoints .......................................................................................... 209 7.4. Sample Size Calculations ..................................................................................... 209 7.5. Analysis Sets ......................................................................................................... 211 7.5.1. Prior Therapies ...................................................................................... 212 7.6. Statistical Analysis Methodology ......................................................................... 213 7.6.1. Analysis of Primary Efficacy Endpoint ................................................. 213 SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 14 7.6.2. Analysis of Secondary Efficacy Endpoints ...........................................