Individual Sections| Overview and Version Control (Download) | 2012-12-12 | 51.87 KB |
| Table of Contents (Download) | 2011-11-15 | 35.72 KB |
| 01: Introduction (Download) | 2011-03-24 | 43 KB |
| 02: Protocol (Download) | 2011-03-24 | 1.16 MB |
| 03: Documentation (Download) | 2011-03-24 | 127.71 KB |
| 04: Accrual v1.4 (Download) | 2012-03-02 | 900.18 KB |
| 05: Informed Consent (Download) | 2011-03-24 | 194.4 KB |
| 06: Follow-up v1.3 (Download) | 2012-12-22 | 331.06 KB |
| 07: Visit Checklists (Download) | 2011-01-01 | 21.46 KB |
| 08: Particpant Rentention (Download) | 2011-03-24 | 36.11 KB |
| 09: Study Product v1.1 (Download) | 2011-05-05 | 118.5 KB |
| 10: Clinical Considerations v1.1 (Download) | 2011-05-05 | 184.07 KB |
| 11: Adverse Event Reporting and Safety Monitoring v1.3 (Download) | 2011-11-15 | 192.08 KB |
| 12: Laboratory Considerations v1.2 (Download) | 2011-08-19 | 485.35 KB |
| 13: Behavioral Assessments (Download) | 2011-03-24 | 78.11 KB |
| 14: Data Collection (Download) | 2011-03-24 | 1.34 MB |
| 15: Data Communiques (Download) | 2011-03-24 | 7.96 KB |
| 15: Data Communiques #1 (Download) | 2011-04-05 | 82.21 KB |
| 15: Data Communiques #2 (Download) | 2011-05-05 | 73.91 KB |
| 15: Data Communiques #3 (Download) | 2011-05-26 | 80.71 KB |
| 15: Data Communiques #4 (Download) | 2011-10-04 | 76.94 KB |
| 15: Data Communiques #5 (Download) | 2011-10-20 | 68.42 KB |
| 15: Data Communiques #6 (Download) | 2012-02-08 | 66.58 KB |
| 15: Data Communiques #7 (Download) | 2013-05-16 | 534.19 KB |
| 16: Study Reporting Plan (Download) | 2011-03-24 | 17.96 KB |
Section Archive: Retired Section Versions| 04: Accrual v1.0 (Download) | 2011-03-24 | 2.38 MB |
| 04: Accrual v1.1 (Download) | 2011-04-18 | 1.01 MB |
| 04: Accrual v1.2 (Download) | 2011-08-26 | 1.02 MB |
| 04: Accrual v1.3 (Download) | 2011-11-15 | 1.05 MB |
| 06: Follow-up v1.0 (Download) | 2011-03-24 | 213.9 KB |
| 06: Follow-up v1.1 (Download) | 2011-04-18 | 217.11 KB |
| 06: Follow-up v1.2 (Download) | 2011-05-18 | 121.45 KB |
| 09: Study Product v1.0 (Download) | 2011-03-24 | 391.27 KB |
| 10: Clinical Considerations v1.0 (Download) | 2011-03-24 | 251.26 KB |
| 11: Adverse Event Reporting and Safety Monitoring v1.0 (Download) | 2011-03-24 | 199.61 KB |
| 11: Adverse Event Reporting and Safety Monitoring v1.1 (Download) | 2011-06-16 | 124.53 KB |
| 11: Adverse Event Reporting and Safety Monitoring v1.2 (Download) | 2011-08-24 | 191.95 KB |
| 12: Laboratory Considerations v1.0 (Download) | 2011-04-11 | 587.55 KB |
| 12: Laboratory Considerations v1.1 (Download) | 2011-05-04 | 484 KB |
