Example Presentation of Results from a Two-Way Factorial …
Jul 17, 2015 · AE Reporting and . Followup. Provide a plan for collecting, reporting, and . followup. of all AEs, including. abnormal lab values. Please refer to Tables 4, 5, and . 6. in Appendix A for suggested formats for data collection and reporting. F. SAE Reporting. Unexpected, serious, and intervention-related SAEs must be reported to the Independent ... ................
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