Open Session

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NHLBI: A monitoring board session which involves discussion of issues relating to the general conduct and progress of the study, including adverse events and toxicity issues, accrual, demographic characteristics of enrollees, disease status of enrollees (if relevant), comparability of groups with respect to baseline factors, protocol compliance, site performance, quality control, and timeliness and completeness of follow-up. Any data provided must be presented without grouping by treatment assignment or otherwise by preserving the masking of all subjects. Outcome results must not be discussed during this session.