50 8.3.1 Evaluable for Toxicity .............................................................................................. 50 8.3.2 Evaluable for Obj ective Response ............................................................................ 50 8.3.3 Evaluable for Non-Target Disease Response ........................................................... 50 Statistical Analyses ....................................................................................................... 50 8.4.1 General Approach ..................................................................................................... 50 8.4.2 Analysis of the Primary Efficacy Endpoints ............................................................. 50 8.4.3 Analysis of the Secondary Efficacy Endpoint .......................................................... 50 8.4.4 Safety Anal yses ......................................................................................................... 51 8.4.5 Intention-to-Treat Analysis ....................................................................................... 51 8.4.6 Planned Interim Analyses ......................................................................................... 518.4.7 Sub-Group Analyses ................................................................................................. 51 9 COLLABORATIVE AGREEMENTS.......................................................................... 51 ModernaTX, Inc. ........................................................................................................... 51 10 HUMAN SUBJECTS PROTECTIONS ........................................................................ 52 Rationale for Patie nt Selection ...................................................................................... 52 Participation of Children ............................................................................................... 52 Participation of Subjects Unable to Give Consent ........................................................ 52 Evaluation of Benefits an d Risks/Discomforts ............................................................. 52 Risk/Benefit Analysis ................................................................................................... 53 Consent Process and Documentation ............................................................................ 53 10.6.1 Telephone Consent for Part One Registration ...................................................... 53 10.6.2 Informed Consent of Non-English Speaking Subjects ......................................... 53 11 PHARMACEUTICAL INFORMATION ..................................................................... 54 Cell Preparation ............................................................................................................ 54 Intramuscular Injection Preparation .............................................................................. 54 11.2.1 NCI-4650, mRNA-Based Personalized Cancer Vaccine ...................................... 54 12 REFERENCES ................................................................................................................