Suggestions(1)
Exact(4)
Figure 1 shows the CONSORT/TREND diagram with the total number of enrolled patients per study stage (randomization and sequential enrolment stage), those assigned, allocated, exposed to the intervention, followed-up, and analyzed, both in the basic effectiveness (n = 151) and intent-to-treat analysis (n = 198).
Randomisation was done for all 24 participants together at the same moment by lottery, thus eliminating selection bias, that can occur with sequential enrolment [ 14].
This was a quasiexperimental study involving the sequential enrolment of 122 pregnant women attending antenatal care who were at a gestational age of between 13 and 28 weeks for the study group and subsequent enrolment of the same one month after for the control.
TIV-AS03C was also highly immunogenic, but the incidence of fever >38.0 °C during 3 d after the first dose was 35.0% (7/20) which fulfilled the pre-defined holding-rule for safety; the GlaxoSmithKline Vaccine Safety Monitoring Board cancelled the second dose of TIV-AS03C and the sequential enrolment of children to receive TIV-AS03B (5.93 mg tocopherol).
Similar(56)
Eligible household contacts were allocated sequential numbers at enrolment and a computer- generated list was used to randomly assign them to receive either IPT and monthly visits or monthly visits only.
Four women were excluded post-randomisation; two women (physical activity group) were enrolled twice in sequential pregnancies (their second enrolment was removed) and two women (control group) were ineligible at their baseline visit and had been randomised erroneously.
Study enrolment occurred in sequential winter respiratory seasons (November to April) from 1999 to 2002.
The Predisposition, Insult/infection, Response, and Organ dysfunction (PIRO) concept of risk assessment may prove more useful than APACHE (Acute Physiology and Chronic Health Evaluation) or SOFA (Sequential Organ Failure Assessment) scores for enrolment and stratification [ 57].
Patient enrolment followed a five-step sequential design.
These numbers were allocated in sequential order and registered in the patient enrolment list and the allocation was concealed.
These numbers were allocated to patients in sequential order and registered in the patient enrolment list and the allocation was concealed.
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