Individual Sections| Overview of Section Contents (Download) | 2014-05-08 | 41.33 KB |
| 01: Introduction (Download) | 2014-03-06 | 63.71 KB |
| 02: Protocol (Download) | 2014-03-06 | 33.75 KB |
| 03: Documentation Requirements (Download) | 2014-03-06 | 295.7 KB |
| 04: Participant Accrual and Enrollment (Download) | 2014-03-06 | 212.25 KB |
| 05: Participant Follow-up (Download) | 2014-03-06 | 163.59 KB |
| 06: Participant Retention (Download) | 2014-03-06 | 180.69 KB |
| 07: Study Product Considerations for Non-Pharmacy Staff (Download) | 2014-03-06 | 420.44 KB |
| 08: Clinical Considerations and Safety Monitoring (Download) | 2014-03-06 | 390.08 KB |
| 09: Laboratory Considerations (Download) | 2014-05-08 | 576.47 KB |
| 10: Data Collection (Download) | 2014-03-06 | 787.7 KB |
| 11: Data Communiqués (Download) | 2013-09-11 | 97.96 KB |
| 12: Counseling Considerations (Download) | 2014-03-06 | 519.03 KB |
| 13: Study Reporting Plan (Download) | 2014-03-06 | 243.03 KB |
