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All completing subjects had CGI-S scores of 3 or less over the majority of the maintenance phase (Table 2).
On the basis of these assumptions, a total of 120 completing subjects in each group would be needed for 80% power at the 5% level of significance.
Strengths of this study include its double-dummy, double-blinded, crossover design in which all completing subjects received both drugs, with the subjects each receiving two injections and one capsule each day.
The calculation was based on considerations for a corresponding TQT trial with only one placebo period, which would achieve the same power with 36 completing subjects, using the following assumptions: 1) An expected difference of approximately 2 ms in the primary endpoint between empagliflozin and placebo, and its common standard deviation of 14 ms.
Assuming a treatment difference of 0.5 mmol/l and a within-patient SD of 1.1 mmol/l, 58 completing subjects would provide 90% power to detect a significant difference between the average 24-h glucose concentrations during treatment with exenatide or sitagliptin.
Similar(55)
Based on previous data, 20 completed subjects were required (5).
Each completed subject survey form was reviewed for completeness prior to analysis by the principal investigator.
Sixty subjects completed the study: one subject withdrew consent.
In this case, no apparent outliers, either in single fits or complete subjects, were apparent.
A significant difference was found when comparing those subjects completing elementary school to those subjects completing high school and college.
Thirty-three subjects were recruited, and 28 subjects completed the study.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com