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Eventually, we identified 39 matched control patients yielding a total study population of 78 patients (Fig. 1).
Results: From a total study population of 1898, 806 patients underwent NIV and 1092 received IMV (Group C).
Questionnaires, where the headache question had not been answered (n = 221) were excluded, leaving a total study population of 8,255 (81%).
Sample size calculations refer to a logRank statistic under α = 0.05 and β = 0.2 (80% power) under the assumptions of (a) an accrual time of 24 months, (b) a total study duration of 48 months, and (c) a drop-out rate of 12% (the latter based on experiences from previous studies).
The response rates to the questionnaire and the two reminders were 19.4%, 11.5% and 9.1%, respectively, which gave a total study group of 2001 individuals.
The observed reductions in both total and percent cystatin C in ALS patients relative to DC may reflect actual differences in clinical cystatin C levels, but a total study enrollment of 1020 and 675 patients (for total and percent cystatin C, respectively) would be required to confirm statistical significance with 80% power and 95% confidence.
We analyzed a total study group of 675 probands.
There will be two months between cycles, resulting in a total study duration of ten months.
This resulted in 23,772 matched controls and a total study population of 30,900 patients.
Both groups were included, yielding a total study size of 8,510 (82%) culture-positive patients.
This resulted in a total study sample of 66 000 women (fig 1).
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