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Consistent with ALFSG studies [16], the primary outcome (Analysis 1) was 21-day LT-free survival (no patients included in the analysis received LT).
Moving forward, planning for and description of secondary analyses in randomized trials should be given equal consideration and care to the primary outcome analysis.
The primary outcome analysis will consist of two sets of statistical analyses, one comparing the effect of nicotine nasal spray to its placebo, and one comparing the effect of varenicline to its placebo, on the proportion of daily cigarettes smoked during the 4-h post-methadone-dosing period.
The study uses a randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis.
Of the 780 children enrolled, 769 (98.6%) completed follow-up and were included in the primary outcome analysis.
All analyses of continuous outcomes will follow the same procedure as the primary outcome analysis.
Primary outcome analysis (nausea in cycle (1) revealed no statistically significant differences between the three groups.
Of these, 60 completed an MMTT at 2 years and contributed to the primary outcome analysis.
For primary outcome analysis, we imputed the outcome of these excluded patients.
The Complete Case (CC) population will be used for the primary outcome analysis.
The primary outcome analysis will be based upon intent-to-treat.
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