| Description | Date | Size |
|---|
| Overview and Control Document – Version History and Notice of Changes (Download) | 2021-11-15 | 1.26 MB |
| Table of Contents - Current Sections (Download) | 2021-11-15 | 110.96 KB |
| Section 01: Introduction (Download) | 2021-11-15 | 188.14 KB |
| Section 02: Documentation Requirements (Download) | 2021-08-24 | 232.16 KB |
| Section 03: Participant Accrual and Retention (Download) | 2021-08-24 | 198.65 KB |
| Section 04: Informed Consent (Download) | 2021-08-24 | 306.42 KB |
| Section 05: Study Procedures (Download) | 2021-11-15 | 560.04 KB |
| Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) | 2021-08-24 | 733.78 KB |
| Section 07: Clinical Considerations (Download) | 2021-11-15 | 791.94 KB |
| Section 08: Adverse Event Reporting and Safety Monitoring (Download) | 2021-11-15 | 933.5 KB |
| Section 09: Counseling Considerations (Download) | 2021-08-24 | 300.06 KB |
| Section 10: Laboratory Considerations (Download) | 2021-11-15 | 820.52 KB |
| Section 11: Data Collection (Download) | 2021-08-24 | 603.84 KB |
| Section 12: Data Communiqués (Download) | 2021-08-24 | 78.19 KB |
| Section 14: DELIVER Qualitative Component (Download) | 2021-11-15 | 667.13 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 13: Study Reporting Plan (Download) | 2021-08-24 | 208.4 KB |
| Protocol Version 2.0 and SSP v2.0 Updates (Download) | 2021-08-26 | 1.71 MB |