| Description | Date | Size |
|---|
| Overview and Control Document – Version History and Notice of Changes (Download) | 2019-12-19 | 983.71 KB |
| Table of Contents - Current Sections (Download) | 2019-12-19 | 213.7 KB |
| Section 01: Introduction (Download) | 2019-12-19 | 306.07 KB |
| Section 02: Documentation Requirements (Download) | 2019-12-19 | 343.88 KB |
| Section 03: Participant Accrual and Retention (Download) | 2019-12-19 | 301.77 KB |
| Section 04: Informed Consent (Download) | 2019-12-19 | 466.11 KB |
| Section 05: Study Procedures (Download) | 2019-12-19 | 715.6 KB |
| Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) | 2019-12-19 | 798.74 KB |
| Section 07: Clinical Considerations (Download) | 2019-12-19 | 947.26 KB |
| Section 08: Adverse Event Reporting and Safety Monitoring (Download) | 2019-12-19 | 1.04 MB |
| Section 09: Counseling Considerations (Download) | 2019-12-19 | 435.8 KB |
| Section 10: Laboratory Considerations (Download) | 2019-12-19 | 1.04 MB |
| Section 11: Data Collection (Download) | 2019-12-19 | 707.87 KB |
| Section 12: Data Communiqués (Download) | 2019-12-19 | 133 KB |
| Section 12: Data Communiqué #1 (Download) | 2020-02-05 | 68.45 KB |
| Section 13: Study Reporting Plan (Download) | 2019-12-19 | 302.26 KB |
| Section 14: DELIVER Qualitative Component (Download) | 2019-12-19 | 968.62 KB |