Individual Sections| Overview of Section Contents (Download) | 2018-07-18 | 370.29 KB |
| Section 01: Introduction (Download) | 2018-07-18 | 325.62 KB |
| Section 02: Documentation Requirements (Download) | 2017-11-20 | 371.95 KB |
| Section 03: Accrual and Retention (Download) | 2017-09-11 | 332.71 KB |
| Section 04: Informed Consent (Download) | 2017-09-11 | 430.52 KB |
| Section 05: Study Procedures (Download) | 2018-04-13 | 494.73 KB |
| Section 06: Study Product Considerations for Non- Pharmacy Staff (Download) | 2017-09-11 | 766.68 KB |
| Section 07: Clinical Considerations (Download) | 2017-11-20 | 827.31 KB |
| Section 08: Adverse Event Reporting and Safety Monitoring (Download) | 2017-09-11 | 522.77 KB |
| Section 09: Laboratory Considerations (Download) | 2017-12-11 | 494.98 KB |
| Section 10: Counseling Considerations (Download) | 2017-09-11 | 420.44 KB |
| Section 11: Behavioral Measures (Download) | 2018-06-20 | 851.11 KB |
| Section 12: Data Collection (Download) | 2018-04-13 | 556.87 KB |
| Section 13: Data Communiqués (Download) | 2017-09-11 | 264 KB |
| Section 13: Data Communiqué #1 (Download) | 2018-01-29 | 33.45 KB |
| Section 13: Data Communiqué #2 (Download) | 2018-04-13 | 62.82 KB |
| Section 13: Data Communiqué #3 (Download) | 2018-06-28 | 40.13 KB |
| Section 14: Study Reporting Plan (Download) | 2017-09-11 | 207.29 KB |
