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One long-standing issue about ambiguity is that it assumes a difference between something like sense and reference.
This assumes a difference between EcN and placebo and differences amongst the 3 EcN groups with increasing efficacy achieved by larger volumes of EcN.
The proposed model assumes a difference between a treatment with optimal adherence (gel), corresponding to 75% in a year, with respect to a treatment involving a drug formulation with lower patient adherence (ointment), which decreases with time.
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We assumed a difference of 1.5 days between both groups with a standard deviation (SD) of 1.5, based on prior preventive clinical trial studies.
Assuming a difference in prevalence of 12%, using a power of 0.80 and a significance level of 5%, a minimum of 280 patients without side shift had to be included in the present study.
The power of the study was 85% with n = 20 in each group, α = 0.05, assuming a difference in PaO2 of 25% with a standard deviation at 0.25 of mean.
Therefore, we considered reasonable to assume a difference in BMI of 0,6 kg/m between control and intervention group.
In the design phase of this trial, we assumed a difference of 15 points between groups to be clinically relevant.
For the a priori power calculations, we assumed a difference between mean glucose incremental AUC of at least 20% and an SD of the difference of 18%.
Assuming a difference between arterial and mixed-venous pCO2 of 2 5 mmHg[ 31] one would expect at least a 2 5 mmHg difference between EtCO2 and venous pCO2.
A comparison between the control group and the intervention groups will require 72 persons in the control group, if we assume a difference of at least 20%.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com