The protocol should provide clear guidance about administration of study medication and other interventions.
After randomisation and immediately prior to the administration of study medication, VRS-PI was measured again and the score was recorded as baseline PI for the efficacy analysis.
Donors are managed using standard CTDN protocols [20] except for the administration of study drug and data collection, with one exception.
Unless otherwise specified, baseline assessment was the latest available valid measurement taken prior to the initial dose administration of study medication, generally Day 0. Missing safety data were not imputed in this study.
The key elements of comparative clinical trial design include issues of enrolment, stratification, randomization, blinding, administration of study drugs, monitoring of drug toxicity, definitions, and key statistical elements of end points, sample size, and tools for data analysis.
The primary safety end point is the composite of major and clinically-relevant non-major bleeding, from the first administration of study drug to end of treatment (Day 28 post cardioversion) +3 days.
Results: Higher rates of global improvement correlated with frequency of administration of study intervention (r =.31, P =.03), duration of the study (r =.28, P =.04), and overall treatment effect of the active agent being studied (r =.33, P =.02).
Field workers visited study children to solicit any adverse events 7 to 10 days after administration of study drugs.
The administration of study drugs will be recorded.
The treatment period extended from the first administration of study drug (week 1) to 4 weeks after the last administration of study drug (week 17) (Fig. 1).
