| Sections |
| Table of Contents | 2008-Apr-14 | 55.29 KB |
| Section 01: Introduction | 2008-Apr-14 | 95.05 KB |
| Section 02: Protocol | 2008-Apr-14 | 52.5 KB |
| Section 03: Documentation Requirements | 2008-Apr-14 | 160.48 KB |
| Section 04: Participant Accrual | 2008-Apr-14 | 111.02 KB |
| Section 05: Informed Consent | 2008-Apr-14 | 116.81 KB |
| Section 06: Participant Follow-up | 2008-Apr-14 | 47.34 KB |
| Section 07: Visit Checklists | 2008-May-31 | 159.69 KB |
| Section 08: Participant Retention | 2008-Apr-14 | 96.95 KB |
| Section 09: Study Product Considerations for Non-Pharmacy Staff | 2008-Apr-14 | 69.41 KB |
| Section 10: Clinical Considerations | 2008-Apr-14 | 156.77 KB |
| Section 11: Adverse Event Reporting and Safety Monitoring | 2008-Aug-25 | 155.8 KB |
| Section 12: Laboratory Considerations | 2008-Apr-14 | 206.29 KB |
| Section 13: Data Collection | 2008-Apr-14 | 697.63 KB |
| Section 14: Data Communiques | 2008-Apr-14 | 12 KB |
| Section 15: Study Reporting Plan | 2008-Apr-14 | 28.29 KB |