| SSPs |
| Overview of Section Contents and Identification of Current Section Versions | 2008-Sep-03 | 93.67 KB |
| Table of Contents | 2008-Jun-23 | 95.93 KB |
| Section 01: Introduction | 2008-May-08 | 95.22 KB |
| Section 02: Protocol | 2008-May-08 | 1.06 MB |
| Section 03: Documentation Requirements | 2008-May-08 | 198.04 KB |
| Section 04: Participant Accrual | 2008-May-14 | 3.01 MB |
| Section 05: Informed Consent | 2008-May-08 | 166.44 KB |
| Section 06: Participant Follow-up | 2008-May-08 | 862.77 KB |
| Section 07: Non-US Visit Checklists | 2008-Sep-03 | 232.27 KB |
| Section 07: US Visit Checklists | 2008-Sep-03 | 225.67 KB |
| Section 08: Participant Retention | 2008-May-08 | 99.51 KB |
| Section 09: Study Product Considerations for Non-Pharmacy Staff | 2008-May-14 | 183.24 KB |
| Section 10: Clinical Considerations | 2008-Sep-03 | 292.64 KB |
| Section 11: Adverse Event Reporting and Safety Monitoring | 2008-May-08 | 545.58 KB |
| Section 12: Laboratory Considerations | 2008-May-08 | 1.07 MB |
| Section 13: Data Collection | 2008-May-08 | 1.85 MB |
| Section 14: Data Communiques | 2008-Jun-17 | 35.78 KB |
| Section 15: Study Reporting Plan | 2008-May-08 | 28.07 KB |
| Section 16: Week 21 In-Depth Interviews | 2008-Jun-23 | 203.34 KB |