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Frequently, trial results are not usable because of bias, which can significantly distort study results, or because of insufficient reporting to determine study quality.
Predefined inclusion criteria based on objective outcome measures of decalcification, duration of treatment, presence of a comparison group, and study design were applied to determine study selection.
These considerations include pediatric-specific disease processes, developmental differences in physiology and metabolism, practical limitations related to physical size, small numbers of subjects available for inclusion in studies, and the need for long-term follow-up to determine study outcomes.
Novel features of the design include a two-tiered study enrollment procedure, which initially enrolls physicians as subjects, and then following recruitment of physicians, enrollment of subjects takes place based initially on an independent assessment by study staff to determine study eligibility.
The main outcome measures were percentages of urine specimens negative for heroin, cocaine, and both simultaneously; these were monitored during a 5-week baseline of standard treatment (to determine study eligibility), a 12-week intervention, and a 10-week maintenance phase (to examine intervention effects in return-to-baseline conditions).
All procedures were carried out with sedated animals and all NiV-infected animals were closely monitored for signs of clinical illness and a general distress and a humane endpoint scoring system was used to determine study endpoint.
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Although the extent of the drug's use within North Korea is difficult to determine, studies have suggested that it has reached "epidemic" levels, and defectors have testified that meth is ingested widely and openly in parts of the country.
Because of the small number of rats used per group in each of the 2-day exposure studies, the variance was heterogeneous, and therefore, we performed no statistical testing to determine study-to-study differences.
Milward-Oliver told the publishing house: "It took many years of determined study, practical application and a large helping of God-given creative genius for Hawkey to arrive at his design.
Two independent reviewers analysed results, determined study eligibility and assessed methodological quality.
Subjects were randomized within 14 days of starting therapy for the OI (or bacterial infection) that determined study eligibility.
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