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A common deviation of this pharmacokinetic model consists on adding a linear term.
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Pex5 recognizes the peroxisomal targeting signal 1 (PTS1), which is composed of a canonical Ser-Lys-Leu tripeptide at the extreme C-terminus with common deviations of the canonical sequence [ 6].
In a two one-sided test analysis for additive equivalence of paired means with bounds -5 and +5 for the mean difference and a significance level of 0.05, assuming a mean difference of 0, a common standard deviation of 16 and correlation 0.9, a sample size of 19 pairs, was required to obtain a power of at least 0.8.
In a two one-sided tests (TOST) analysis for additive equivalence of two-sample normal means with bounds -12 and 12 for the mean difference and a significance level of 0.05, assuming a null difference and a common standard deviation of 25%, a sample size of 76 patients with arm lymphedema per group is required to obtain a power of at least 0.8.
In a two-sided tests analysis for additive equivalence of paired means for a given KOOS with bounds -5 and 5 for the mean difference and a significance level of 0.05, assuming a mean difference of 0 KOOS points, a common Standard Deviation of 20, and correlation 0.95, a sample size of 20 pairs yielded a power of 0.922 (> 90%).
A two-group ranked analysis of variance with a 0.05 type I error was employed with at least 85% power to detect the difference between an adalimumab mean of 0.2 and a historical control mean of 1.2, a difference in means of 1.0, with the assumption of a common standard deviation of 2.8.
Based on a two-group one-sided t test with significance level of 0.025, a sample size of 29 patients per group was calculated to have 80%% power to reject the null hypothesis, assuming an expected difference in means of 0, a common standard deviation of 0.4, and a non-inferiority lower limit of 0.3 mm.
Taking into account the effect of PMT, we conservatively estimated an ES of Cohen's d = 0.5 for the difference between treatment with one and two drugs, where there would be a difference of 5.5 and a common standard deviation of 11 in the NCBRF D-Total change scores between the two treatment groups.
Assuming an expected mean difference of 0.25 days with a common standard deviation of 1.5 days, a 10% dropout rate and a noninferiority margin of −1 day, 96 patients per group (biosimilar or reference) were required to have 90% power for showing noninferiority based on a one-sided 97.5% CI.
Assuming a possible difference in mean intubation time of 10 s and a common standard deviation of 12 s in each of the groups based on our pilot data and other publications [ 13- 15], a sample size of 30 patients in each group would be necessary.
Koff et al. [ 51] published a difference in change of 9 between the two groups (standard care, standard care with proactive palliative care) with a common standard deviation of the change of 16.
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