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DescriptionDateSize
Individual Sections
Overview and Version Control (Download) 2012-12-1251.87 KB
Table of Contents (Download) 2011-11-1535.72 KB
01: Introduction (Download) 2011-03-2443 KB
02: Protocol (Download) 2011-03-241.16 MB
03: Documentation (Download) 2011-03-24127.71 KB
04: Accrual v1.4 (Download) 2012-03-02900.18 KB
05: Informed Consent (Download) 2011-03-24194.4 KB
06: Follow-up v1.3 (Download) 2012-12-22331.06 KB
07: Visit Checklists (Download) 2011-01-0121.46 KB
08: Particpant Rentention (Download) 2011-03-2436.11 KB
09: Study Product v1.1 (Download) 2011-05-05118.5 KB
10: Clinical Considerations v1.1 (Download) 2011-05-05184.07 KB
11: Adverse Event Reporting and Safety Monitoring v1.3 (Download) 2011-11-15192.08 KB
12: Laboratory Considerations v1.2 (Download) 2011-08-19485.35 KB
13: Behavioral Assessments (Download) 2011-03-2478.11 KB
14: Data Collection (Download) 2011-03-241.34 MB
15: Data Communiques (Download) 2011-03-247.96 KB
15: Data Communiques #1 (Download) 2011-04-0582.21 KB
15: Data Communiques #2 (Download) 2011-05-0573.91 KB
15: Data Communiques #3 (Download) 2011-05-2680.71 KB
15: Data Communiques #4 (Download) 2011-10-0476.94 KB
15: Data Communiques #5 (Download) 2011-10-2068.42 KB
15: Data Communiques #6 (Download) 2012-02-0866.58 KB
15: Data Communiques #7 (Download) 2013-05-16534.19 KB
16: Study Reporting Plan (Download) 2011-03-2417.96 KB
Section Archive: Retired Section Versions
04: Accrual v1.0 (Download) 2011-03-242.38 MB
04: Accrual v1.1 (Download) 2011-04-181.01 MB
04: Accrual v1.2 (Download) 2011-08-261.02 MB
04: Accrual v1.3 (Download) 2011-11-151.05 MB
06: Follow-up v1.0 (Download) 2011-03-24213.9 KB
06: Follow-up v1.1 (Download) 2011-04-18217.11 KB
06: Follow-up v1.2 (Download) 2011-05-18121.45 KB
09: Study Product v1.0 (Download) 2011-03-24391.27 KB
10: Clinical Considerations v1.0 (Download) 2011-03-24251.26 KB
11: Adverse Event Reporting and Safety Monitoring v1.0 (Download) 2011-03-24199.61 KB
11: Adverse Event Reporting and Safety Monitoring v1.1 (Download) 2011-06-16124.53 KB
11: Adverse Event Reporting and Safety Monitoring v1.2 (Download) 2011-08-24191.95 KB
12: Laboratory Considerations v1.0 (Download) 2011-04-11587.55 KB
12: Laboratory Considerations v1.1 (Download) 2011-05-04484 KB