Individual Sections| Overview and Version Control (Download) | 2012-05-21 | 227.63 KB |
| Table of Contents (Download) | 2011-09-14 | 116.28 KB |
| Section 01: Introduction (Download) | 2011-09-02 | 101.2 KB |
| Section 02: Protocol (Download) | 2011-12-19 | 65.94 KB |
| Section 03: Documentation Requirements (Download) | 2011-09-02 | 218.69 KB |
| Section 04: Participant Accrual (Download) | 2011-12-19 | 401.15 KB |
| Section 05: Informed Consent (Download) | 2012-01-13 | 99.09 KB |
| Section 06: Participant Follow-up (Download) | 2012-05-21 | 560.55 KB |
| Section 07: Visit Checklists (Download) | 2011-12-19 | 141.95 KB |
| Section 08: Participant Retention (Download) | 2011-09-02 | 129.37 KB |
| Section 09: Study Product Considerations for Non-Pharmacy Staff (Download) | 2011-09-02 | 1.96 MB |
| Section 10: Clinical Considerations (Download) | 2012-04-13 | 635.85 KB |
| Section 11: Adverse Event Reporting and Safety Monitoring (Download) | 2011-11-04 | 295.61 KB |
| Section 12: Laboratory Considerations (Download) | 2012-04-13 | 1.17 MB |
| Section 13: Data Collection (Download) | 2011-09-14 | 942.24 KB |
| Section 14: Data Communiques (Download) | 2011-09-02 | 52.46 KB |
| Section 14: Data Communiques #1 (Download) | 2011-09-15 | 21.87 KB |
| Section 14: Data Communiques #2 (Download) | 2011-12-14 | 56.29 KB |
| Section 14: Data Communiques #3 (Download) | 2011-12-19 | 40.13 KB |
| Section 14: Data Communiques #4 (Download) | 2012-02-15 | 24.83 KB |
| Section 14: Data Communiques #5 (Download) | 2012-04-27 | 20.42 KB |
| Section 14: Data Communiques #6 (Download) | 2012-05-23 | 25.64 KB |
| Section 15: Study Reporting Plan (Download) | 2011-09-02 | 74.03 KB |
| Section 16: Behavioral Measures: CASI Questionnaires and the Semi-Structured Interview (SSI) (Download) | 2012-03-21 | 810.41 KB |
| Section 17: Counseling Considerations (Download) | 2011-12-19 | 230.31 KB |
