Individual Sections| Overview and Control Document – Version History and Notice of Changes (Download) | 2020-10-12 | 1 MB |
| Table of Contents (Download) | 2020-10-12 | 211.57 KB |
| Section 01: Introduction (Download) | 2020-08-17 | 252.43 KB |
| Section 02: Documentation Requirements (Download) | 2019-11-15 | 211.7 KB |
| Section 03: Accrual and Retention (Download) | 2020-08-17 | 219.4 KB |
| Section 04: Informed Consent (Download) | 2019-11-15 | 167.24 KB |
| Section 05: Study Procedures (Download) | 2020-08-17 | 369.21 KB |
| Section 06: Counseling Considerations (Download) | 2020-04-22 | 210.82 KB |
| Section 07: Behavioral Measures (Download) | 2019-11-15 | 257.99 KB |
| Section 08: Study Product Considerations for Non-Pharmacy Staff (Download) | 2019-11-15 | 392.59 KB |
| Section 09: Clinical Considerations (Download) | 2020-10-12 | 450.54 KB |
| Section 10: Adverse Event Reporting and Safety Monitoring (Download) | 2020-04-22 | 348.16 KB |
| Section 11: Laboratory Considerations (Download) | 2020-10-12 | 713.67 KB |
| Section 12: Data Collection (Download) | 2020-10-12 | 650.35 KB |
| Section 13: Data Communiqués (Download) | 2019-11-15 | 79.83 KB |
| Section 13: Data Communiqué #1 (Download) | 2020-04-16 | 196.45 KB |
| Section 13: Data Communiqué #2 (Download) | 2020-05-19 | 173.07 KB |
| Section 13: Data Communiqué #3 (Download) | 2021-04-06 | 161.9 KB |
| Section 14: Study Reporting Plan (Download) | 2019-11-15 | 166.41 KB |
