214 7.6.3. Analyses of Exploratory Endpoint ........................................................ 214 7.6.4. Safety Analyses ..................................................................................... 214 7.6.4.1. Adverse Events ...................................................................................... 215 7.6.4.2. Laboratory Test Results ......................................................................... 215 7.6.4.3. 12-Lead Electrocardiogram Results ...................................................... 216 7.6.4.4. Physical Examination ............................................................................ 216 7.6.4.5. Vital Signs ............................................................................................. 216 7.6.4.6. Eastern Cooperative Group Performance Status ................................... 216 7.6.5. Interim Analyses .................................................................................... 216 7.6.6. Go/No-Go and Futility Monitoring Guidelines ..................................... 217 7.7. Data Quality Assurance ........................................................................................ 219 7.7.1. Data Management .................................................................................. 219 8. Ethics .............................................................................................................................. 221 8.1. Independent Ethics Committee or Institutional Review Board ............................ 221 8.2. Ethical Conduct of the Study ................................................................................ 221 8.3. Patient Information and Consent .......................................................................... 222 9. Investigator’s Obligations .............................................................................................. 223 9.1. Confidentiality ...................................................................................................... 223 9.2. Financial Disclosure and Obligations ................................................................... 224 9.3. Investigator Documentation ................................................................................. 224 9.4. Study Conduct ...................................................................................................... 225 9.5. Adherence to Protocol .......................................................................................... 225 SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 15 9.6. Adverse Events and Study Report Requirements .................................................