Individual Sections| Overview and Control Document – Version History and Notice of Changes (Download) | 2020-07-16 | 546.77 KB |
| Table of Contents - Current Sections (Download) | 2020-07-16 | 180.25 KB |
| Section 01: Introduction (Download) | 2020-07-16 | 208.7 KB |
| Section 02: Documentation Requirements (Download) | 2019-11-12 | 187.43 KB |
| Section 03: Accrual, Eligibility Determination and Study Procedures (Download) | 2019-11-12 | 445.88 KB |
| Section 04: Informed Consent (Download) | 2019-11-12 | 249.74 KB |
| Section 05: Safety and Counseling Considerations (Download) | 2019-11-12 | 214.13 KB |
| Section 06: Data Collection and Management (Download) | 2019-11-12 | 699.3 KB |
| Section 07: Data Communiqués (Download) | 2019-11-12 | 128.76 KB |
| Section 07: Data Communiqué #1 (Download) | 2020-08-14 | 221.6 KB |
