........... 57 8.4.5 Baseline Descriptive Statistics ................................ ................................ .................... 58 8.4.6 Planned Interim Analyses and Halting Guidelines ................................ ..................... 58 8.4.7 Sub-Group Analyses ................................ ................................ ................................ ...58 8.4.8 Tabulation of Individual Participant Data ................................ ................................ ..58 8.4.9 Exploratory Analyses (Immune Responses) ................................ ............................... 58 9 COLLABORATIVE AGREEM ENTS ................................ ................................ ................... 59 9.1 COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT (CRADA) ............................ 59 10 HUMAN SUBJECTS PROTE CTIONS ................................ ................................ ................. 59 10.1 RATIONALE FOR SUBJECT SELECTION ................................ ................................ ................. 59 10.1.1 Selection Based on Gender, Ethnicity, and Race ................................ ....................... 59 10.1.2 Strategies/Procedures for Recruitment ................................ ................................ .......59 10.1.3 Justification for Exclusions ................................ ................................ ......................... 59 10.2 PARTICIPATION OF CHILDREN ................................ ................................ ............................. 59 10.3 PARTICIPATION OF SUBJECTS UNABLE TO GIVE CONSENT ................................ .................. 59 10.4 EVALUATION OF BENEFITS AND RISKS/DISCOMFORTS ................................ ........................ 60 10.5 CONSENT PROCESS AND DOCUMENTATION ................................ ................................ ......... 60 10.5.1 Telephone re -consent procedure ................................ ................................ ................. 60 10.5.2 Consent process for non -English speaking subjects ................................ ................... 61 11 PHARMACEUTICAL INFOR MATION ................................ ................................ .............. 61 11.1 COMBINATION ETBX -011, ETBX -051, ETBX -061 VACCINE REGIMEN ............................ 61 11.1.1 Source ................................ ................................ ................................