Individual Sections| Overview and Control Document – Version History and Notice of Changes (Download) | 2022-05-10 | 1.31 MB |
| Table of Contents - Current Sections (Download) | 2022-05-10 | 68.87 KB |
| Section 01: Introduction (Download) | 2022-05-10 | 135.22 KB |
| Section 02: Documentation Requirements (Download) | 2021-08-24 | 232.16 KB |
| Section 03: Participant Accrual and Retention (Download) | 2022-05-10 | 202.16 KB |
| Section 04: Informed Consent (Download) | 2021-08-24 | 306.42 KB |
| Section 05: Study Procedures (Download) | 2022-05-10 | 457.18 KB |
| Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) | 2021-08-24 | 733.78 KB |
| Section 07: Clinical Considerations (Download) | 2022-05-10 | 633.91 KB |
| Section 08: Adverse Event Reporting and Safety Monitoring (Download) | 2022-05-10 | 811.68 KB |
| Section 09: Counseling Considerations (Download) | 2022-05-10 | 214.55 KB |
| Section 10: Laboratory Considerations (Download) | 2022-05-10 | 687.23 KB |
| Section 11: Data Collection (Download) | 2022-05-10 | 484.51 KB |
| Section 12: Data Communiqués (Download) | 2021-08-24 | 78.19 KB |
| Section 12: Data Communiqué #1 (Download) | 2020-02-05 | 68.45 KB |
| Section 12: Data Communiqué #2 (Download) | 2020-04-09 | 61.54 KB |
| Section 12: Data Communiqué #3 (Download) | 2020-10-29 | 36.51 KB |
| Section 12: Data Communiqué #4 (Download) | 2020-11-25 | 30.03 KB |
| Section 12: Data Communiqué #5 (Download) | 2021-01-26 | 63.76 KB |
| Section 12: Data Communiqué #6 (Download) | 2021-04-18 | 54.99 KB |
| Section 12: Data Communiqué #7 (Download) | 2021-12-21 | 179.3 KB |
| Section 12: Data Communiqué #8 (Download) | 2022-02-22 | 179.39 KB |
| Section 12: Data Communiqué #9 (Download) | 2022-04-05 | 179.03 KB |
| Section 12: Data Communiqué #10 (Download) | 2022-08-08 | 175.57 KB |
| Section 12: Data Communiqué #11 (Download) | 2023-05-04 | 123.11 KB |
| Section 12: Data Communiqué #12 (Download) | 2023-06-23 | 174.52 KB |
| Section 12: Data Communiqué #13 (Download) | 2023-06-30 | 158.15 KB |
| Section 13: Study Reporting Plan (Download) | 2022-05-10 | 144.63 KB |
| Section 14: DELIVER Qualitative Component (Download) | 2022-05-10 | 663.69 KB |
