166 5.4.2. Test Article Accountability ................................................................... 167 5.4.3. Other Supplies ....................................................................................... 168 5.4.4. Blinding ................................................................................................. 168 5.4.5. Breaking the Blind ................................................................................. 168 5.5. Treatment Compliance ......................................................................................... 168 5.6. Prior and Concomitant Therapy ........................................................................... 168 5.7. Rescue Medications and Supportive Care ............................................................ 170 5.7.1. Supportive Care Guidelines for Pembrolizumab ................................... 170 5.8. Diet/Activity/Other Considerations ...................................................................... 171 6. Study Assessments and Procedures ................................................................................... 173 6.1. Study Visits ........................................................................................................... 185 6.1.1. Screening Period and Enrollment .......................................................... 185 6.1.2. Open-Label Treatment Period ............................................................... 185 6.1.3. End of Treatment/Early Termination Visit ............................................ 185 6.1.4. Safety Follow-up Period ........................................................................ 185 6.1.5. Relapse Visit .......................................................................................... 186 6.1.6. Unscheduled Visits ................................................................................ 187 6.2. Efficacy Assessments ........................................................................................... 187 6.3. Exploratory Assessments ...................................................................................... 188 6.4. Safety Assessments ............................................................................................... 191 6.4.1. Adverse Events ...................................................................................... 191 6.4.1.1. Definitions of Adverse Events ............................................................... 191 6.4.1.2. Eliciting and Documenting Adverse Events .......................................... 192 SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 13 6.4.1.3. Reporting Adverse Events .....................................................................