38 8.4.7 Sub-Group Analyses ........................................ ......................................................... 38 8.4.8 Tabulation of individual Participant Data...................... ........................................... 38 8.4.9 Exploratory Analyses........................................... ..................................................... 38 9 COLLABORATIVE AGREEMENTS...................................... .................................... 38 10 HUMAN SUBJECTS PROTECTIONS........................................................................ 39 Rationale for Pa tient Selection...................................................................................... 39 Participation of Children............................................................................................... 39 Participation of Subjects Unable to Give Consent............... ......................................... 39 Evaluation of Benefits an d Risks/Discomforts................... .......................................... 39 Risk/Benefit Analysis ................................................................................................... 40 Consent Process and Documentation.............................. .............................................. 40 10.6.1 Informed Consent of Non-E nglish Speaking Subjects .............. ...........................