41 6.1 Investigational Study Drug Accountability ................................................ 41 6.2 Assessment of Study Drug Compliance ................................................... 41 6.3 Disposal of Drug Supplies ........................................................................ 41 6.4 PROSTVAC -V/F ...................................................................................... 42 6.5 GM-CSF ................................................................................................... 42 6.6 Subject Instructions and Supplies ............................................................ 43 6.7 Dose Reductions and Contraindications for PROSTVAC -V/F ................. 43 6.8 Procedures for Potential Serious Vaccinia Reaction ................................ 43 6.9 Concomitant and Excluded Medications .................................................. 44 6.10 Overdose ................................................................................................. 44 7.0 STUDY PROCEDURES BY STUDY PERIOD ................................................... 45 7.1 Screening Assessments (Days – 28 –1) ................................................... 45 7.2 Day 1 (Day of first dose of PROSTVAC -V/F or placebo), Week 1 ........... 46 7.3 Week 3 Through Week 21 (booster vaccinations) ................................... 47 7.4 End-of-Treatment Visit – Week 25 or When A Subject Discontinues Treatment ................................................................................................ 48 7.5 Assessments During Long -Term Follow -Up ............................................ 49 7.6 Safety Assessments ................................................................................ 50 7.7 Biological and Immune Response Assessments ..................................... 50 7.8 Laboratory Tests and Radiological Assessments .................................... 50 8.0 ADVERSE EVENTS ........................................................................................... 52 8.1 Investigator’s Responsibilities .................................................................. 52 8.2 Definition of Adverse Events (AE) ............................................................ 52 8.3 Definition of Expected and Unexpected Events ....................................... 53 8.4 Collecting and Recording Adverse Events ............................................... 54 8.5 Assessment of Relationship to Study Drug (Causality) ............................ 56 8.6 Severity of Adverse Events (Grading) ...................................................... 56 8.7 Dose Modifications for Toxicity ................................................................ 57 8.8 Definition of Serious Adverse Events ....................................................... 57 8.9 Definition of Unexpected Serious Adverse Events ................................... 58 8.10 Definition of Suspected Adverse Reaction ............................................... 58 8.11 Documenting and Reporting of Adverse Events and Serious Adverse Events ...................................................................................................... 59 8.12 Adverse Event Reporting Period .............................................................. 60 Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2.7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 5 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. 8.13 Assessment of Adverse Events ...............................................................