In PROWESS, this enrollment sequence effect reduced the observed treatment effect associated with DrotAA.
In ADDRESS, this enrollment sequence effect may have contributed to the decision to recommend early termination of the study for futility.
The obvious variation in the enrollment for this study was that children were enrolled on the basis of having any diarrheal syndrome, rather than specifically targeting those with dysentery and suspected shigellosis.
interviewed 8 of the 11 students about their experience using clickers in this small-enrollment course.
To evaluate the effect of collaborative testing on content retention in this large-enrollment introductory biology course, we employed a randomized cross-over design (Cortright et al., 2003; Sandahl, 2010).
Initially, up to 54 evaluable patients were to be enrolled in this study, with enrollment proceeding in 2 stages.
Exclusion criteria included the following: type 1 diabetes, history of severe hypoglycemia within the past 2 years, known or suspected end-stage liver disease, cardiogenic shock at presentation, documented pregnancy, life expectancy of <90 days, anticipated poor adherence or loss to follow-up, and prior enrollment in this trial or current enrollment in another trial of AMI.
In this design, patient enrollment does not need to stop when transitioning from the evaluation of the dose safety and tolerability to the assessment of its efficacy.
In this setting, ART enrollment fluctuated over the years but consistently declined from 2009 to 2011.
An additional change in this amendment allowed enrollment for patients with thromboembolic events (TEEs) > 6 months previously; prior to this amendment patients with a history of TEEs were excluded from the study.
