| Individual Sections |
| Overview and Version Control | 2012-Apr-13 | 226.46 KB |
| Table of Contents | 2011-Sep-14 | 116.28 KB |
| Section 01: Introduction | 2011-Sep-02 | 101.2 KB |
| Section 02: Protocol | 2011-Dec-19 | 65.94 KB |
| Section 03: Documentation Requirements | 2011-Sep-02 | 218.69 KB |
| Section 04: Participant Accrual | 2011-Dec-19 | 401.15 KB |
| Section 05: Informed Consent | 2012-Jan-13 | 99.09 KB |
| Section 06: Participant Follow-up | 2012-Apr-13 | 558.8 KB |
| Section 07: Visit Checklists | 2011-Dec-19 | 141.95 KB |
| Section 08: Participant Retention | 2011-Sep-02 | 129.37 KB |
| Section 09: Study Product Considerations for Non-Pharmacy Staff | 2011-Sep-02 | 1.96 MB |
| Section 10: Clinical Considerations | 2012-Apr-13 | 635.85 KB |
| Section 11: Adverse Event Reporting and Safety Monitoring | 2011-Nov-04 | 295.61 KB |
| Section 12: Laboratory Considerations | 2012-Apr-13 | 1.17 MB |
| Section 13: Data Collection | 2011-Sep-14 | 942.24 KB |
| Section 14: Data Communiques | 2011-Sep-02 | 52.46 KB |
| Section 14: Data Communiques #1 | 2011-Sep-15 | 21.87 KB |
| Section 14: Data Communiques #2 | 2011-Dec-14 | 56.29 KB |
| Section 14: Data Communiques #3 | 2011-Dec-19 | 40.13 KB |
| Section 14: Data Communiques #4 | 2012-Feb-15 | 24.83 KB |
| Section 14: Data Communiques #5 | 2012-Apr-27 | 20.42 KB |
| Section 15: Study Reporting Plan | 2011-Sep-02 | 74.03 KB |
| Section 16: Behavioral Measures: CASI Questionnaires and the Semi-Structured Interview (SSI) | 2012-Mar-26 | 452.46 KB |
| Section 17: Counseling Considerations | 2011-Dec-19 | 230.31 KB |
