Individual Sections| Overview and Version Control (Download) | 2011-04-14 | 41.76 KB |
| Table of Contents (Download) | 2011-03-18 | 88.12 KB |
| Section 01: Introduction (Download) | 2011-03-18 | 81.96 KB |
| Section 02: Protocol (Download) | 2011-03-18 | 469.9 KB |
| Section 03: Documentation Requirements (Download) | 2011-03-18 | 152.2 KB |
| Section 04: Participant Accrual and Enrollment (Download) | 2011-03-18 | 802.08 KB |
| Section 05: Participant Follow-up/Visit Checklists (Download) | 2011-03-18 | 202.68 KB |
| Section 06: Participant Retention (Download) | 2011-03-18 | 96.8 KB |
| Section 07: Study Product Considerations for Non-Pharmacy Staff (Download) | 2011-03-18 | 1.11 MB |
| Section 08: Clinical Considerations and Safety Monitoring (Download) | 2011-03-18 | 285.47 KB |
| Section 09: Laboratory Considerations (Download) | 2011-04-14 | 871.65 KB |
| Section 10: Data Collection (Download) | 2011-03-18 | 354.19 KB |
| Section 11: Data Communiques (Download) | 2011-03-18 | 7.73 KB |
| Section 11: Data Communiques #1 (Download) | 2011-04-05 | 62.82 KB |
| Section 12: Behavioral Measures: Web-based Questionnaires (Download) | 2011-03-18 | 447.41 KB |
| Section 13: Study Reporting Plan (Download) | 2011-03-18 | 17.54 KB |
