Table of Contents 0 Abbreviations and Definitions of Terms 0 Protocol Synopsis 0 1 BACKGROUND AND RATIONALE 0 2 STUDY 0 3 INVESTIGATIONAL PLAN 0 4 STUDY PROCEDURES 0 5 EVALUATIONS AND MEASUREMENTS 0 6 STATISTICAL CONSIDERATIONS 0 7 STUDY INTERVENTION (DEVICE INTERVENTION) 0 8 STUDY INTERVENTION ADMINISTRATION 0 9 SAFETY MANAGEMENT 0 10 DATA COLLECTION AND MANAGEMENT 0 11 RECRUITMENT STRATEGY 0 12 CONSENT PROCESS 0 13 PUBLICATION 0 14 0 Appendix 0
Table of Contents 0 Abbreviations and Definitions of Terms 0 Protocol Synopsis 0 1 0 2 0 3 0 4 0 5 0 6 STATISTICAL CONSIDERATIONS 0 7 (DEVICE INTERVENTION) 0 8 ADMINISTRATION 0 9 SAFETY MANAGEMENT 0 10 COLLECTION AND MANAGEMENT 0 11 RECRUITMENT STRATEGY 0 12 CONSENT PROCESS 0 13 PUBLICATION 0 14 0 Appendix 0 BACKGROUND RATIONALE STUDY INVESTIGATIONAL PLAN STUDY PROCEDURES EVALUATIONS AND MEASUREMENTS STUDY INTERVENTION STUDY INTERVENTION DATA AND