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Fields Changed

Trial
Field Before After
Last Published May 21, 2021 04:20 PM July 28, 2021 12:57 PM
Planned Number of Clusters 500 The originally-specified sample was 500 participants. Recruitment has been more challenging than expected, so we are committing to a date rather than sample cutoff -- the final sample will be the N collected as of October 25, 2021. At the time of this update, N = 121.
Planned Number of Observations 3,000 N x 6
Sample size (or number of clusters) by treatment arms 500 N
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