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From August 2006 to December 2007, 46 patients with recurrent or metastatic biliary tract adenocarcinoma were enrolled into this phase II trial; enrolment was expanded to 46 patients because 14 patients discontinued the treatment within 45 days from study entry.
The revised flow diagram depicts information from four stages of a trial (enrolment, intervention allocation, followup, and analysis).
Patients should therefore be screened to detect headache before clinical trial enrolment and headache sufferers should be separately assessed.
Our patients also had a wider range of co-morbidities which may have excluded them from clinical trial enrolment.
The conduct of Phase I/II HIV vaccine trials internationally necessitates the development of region-specific clinical reference ranges for trial enrolment and participant monitoring.
Based on the distribution of children who had not received OPV, OPV was missing at one or more inclusion sites 1) from the beginning of February 2004 to the beginning of June 2004, 2) briefly in late June 2004, and 3) from mid-October 2004 to the trial enrolment ended in November 2004 (Figure 1).
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Eligible study designs include randomised controlled trials, cluster randomised controlled trials, staggered enrolment trials, stepped wedged trials, quasi-randomised trials, quasi-experimental trials, time series/interrupted time-series trials, preference trials, regression discontinuity trials and natural experiment studies with a parallel control group.
Randomised controlled trials, staggered enrolment trials, stepped-wedged trials, quasi-randomised trials, quasi-experimental trials and natural experiments will be included.
For sepsis trials, enrolment has previously relied upon physiological and biochemical criteria, but greater e orts should be made to identify the patient's immunological/biological phenotype to reduce heterogeneity.
The registration policy is applicable to any trial starting enrolment after 1 July 2005.
An interim analysis will only be conducted to check that the planned number of participants have been retained in the trial following enrolment.
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CEO of Professional Science Editing for Scientists @ prosciediting.com