Individual Sections| Overview and Control Document – Version History and Notice of Changes (Download) | 2018-08-06 | 429.12 KB |
| Table of Contents - Current Sections (Download) | 2018-08-06 | 63.22 KB |
| Section 01: Introduction (Download) | 2018-08-06 | 349.08 KB |
| Section 02: Documentation Requirements (Download) | 2018-08-06 | 621 KB |
| Section 03: Accrual and Eligibility Determination (Download) | 2018-08-06 | 484.94 KB |
| Section 04: Informed Consent (Download) | 2018-08-06 | 596.7 KB |
| Section 05: Study Visit Procedures (Download) | 2018-08-06 | 1.18 MB |
| Section 06: Safety and Counseling Considerations (Download) | 2018-08-06 | 329.33 KB |
| Section 07: Data Management (Download) | 2018-08-06 | 1.16 MB |
| Section 08: Data Communiques (Download) | 2018-08-06 | 277.21 KB |
| Section 08: Data Communique #1 (Download) | 2016-04-29 | 76.88 KB |
| Section 08: Data Communique #2 (Download) | 2016-07-08 | 98.09 KB |
| Section 08: Data Communiqué #3 (Download) | 2016-08-23 | 77.19 KB |
| Section 08: Data Communiqué #4 (Download) | 2018-03-12 | 82.3 KB |
| Section 08: Data Communiqué #5 (Download) | 2018-08-03 | 155.29 KB |
