| Description | Date | Size |
|---|
| Overview and Control Document - Version History and Notice of Changes (Download) | 2019-01-04 | 833.76 KB |
| Table of Contents - Current Sections (Download) | 2019-01-04 | 66.56 KB |
| Section 01: Introduction (Download) | 2019-01-14 | 363.05 KB |
| Section 02: Documentation Requirements (Download) | 2019-01-04 | 252.29 KB |
| Section 03: Participant Accrual and Retention (Download) | 2019-01-04 | 406.87 KB |
| Section 04: Informed Assent and Consent (Download) | 2019-01-04 | 682.87 KB |
| Section 05: Study Procedures (Download) | 2019-01-04 | 568.01 KB |
| Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) | 2019-01-04 | 583.71 KB |
| Section 07: Clinical Considerations (Download) | 2019-01-04 | 683.03 KB |
| Section 08: Adverse Event Reporting and Safety Monitoring (Download) | 2019-01-04 | 782.2 KB |
| Section 09: Laboratory Considerations (Download) | 2019-01-04 | 1.22 MB |
| Section 10: Counseling Procedures (Download) | 2019-01-04 | 496.51 KB |
| Section 11: Behavioral Assessments (Download) | 2019-01-04 | 1.11 MB |
| Section 12: Data Collection (Download) | 2019-01-04 | 980.65 KB |
| Section 13: Data Communiqués (Download) | 2019-01-04 | 132.51 KB |
| Section 13: Data Communiqués #1 (Download) | 2018-11-01 | 103.64 KB |
| Section 13: Data Communiqués #2 (Download) | 2019-03-13 | 115.04 KB |
| Section 14: Study Reporting Plan (Download) | 2019-01-04 | 517.4 KB |