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DonShimoda

01/16/11 10:15 AM

#4919 RE: ariadndndough #4915

The primary completion date occurred in October. The change in the "study completion date" simply means that the company expects to continue to collect data until June 2011.

Primary Completion Date
Definition: As specified in US Public Law 110-85, Title VIII, Section 801, with respect to an applicable clinical trial, the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated. A "Type" menu is also included, with options Anticipated and Actual. For active studies, set Type to Anticipated and specify the expected completion date, updating the date as needed over the course of the study. Upon study completion, change Type to Actual and update the date if necessary.

Study Completion Date
Definition: Final date on which data was (or is expected to be) collected. Use the Type menu (Anticipated/Actual) as described above.