| Description | Date | Size |
|---|
| Overview and Control Document – Version History and Notice of Changes (Download) | 2021-02-01 | 849.56 KB |
| Table of Contents - Current Sections (Download) | 2021-02-01 | 101.66 KB |
| Section 01: Introduction (Download) | 2020-06-30 | 187.96 KB |
| Section 02: Documentation Requirements (Download) | 2019-12-19 | 343.88 KB |
| Section 03: Participant Accrual and Retention (Download) | 2020-06-30 | 198.56 KB |
| Section 04: Informed Consent (Download) | 2019-12-19 | 466.11 KB |
| Section 05: Study Procedures (Download) | 2020-06-30 | 557.19 KB |
| Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) | 2020-04-09 | 689.44 KB |
| Section 07: Clinical Considerations (Download) | 2020-04-09 | 824.52 KB |
| Section 08: Adverse Event Reporting and Safety Monitoring (Download) | 2020-06-30 | 880.93 KB |
| Section 09: Counseling Considerations (Download) | 2020-04-09 | 289.5 KB |
| Section 10: Laboratory Considerations (Download) | 2021-02-01 | 830.49 KB |
| Section 11: Data Collection (Download) | 2020-06-30 | 726.43 KB |
| Section 12: Data Communiqués (Download) | 2019-12-19 | 133 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 13: Study Reporting Plan (Download) | 2019-12-19 | 302.26 KB |
| Section 14: DELIVER Qualitative Component (Download) | 2020-04-09 | 673.05 KB |