Exact(14)
This manuscript provides recommendations regarding best practices in trial design, data collection and analysis regarding bleeding data in combined hormone contraception trials.
Gender and GI bleeding data were converted to binary features.
UGI bleeding data were available in all eight trials [ 11– 16, 22, 28].
Finally, we used the major bleeding data of RECORD studies from the FDA in the main analysis and major bleeding data from the publications as an additional sensitivity analysis.
Based on these bleeding data, some commenters have speculated that the intermediate dose of apixaban 2.5 mg may be most beneficial in extended treatment.
Similar to the primary endpoint, in order to correct for competing risks, a cumulative incidence approach will be used to analyse bleeding data.
Similar(46)
First, considering the 3 week bleed data (Fig 3a, upper panel) in needle and syringe vaccinated mice, reducing the dose by 10-fold gave a significantly lower response (p = 0.029, Mann-Whitney U test), and by a further 10-fold gave a weak but measureable response in only 3 of 4 animals.
Tail bleeding assay data were analysed using t-test.
There are also concerns regarding the manner in which major bleeding complication data were handled.
Additionally, Liu et al.'s study [ 28] had no bleeding events data.
We report detailed a priori subgroup analyses for stroke or systemic embolism and major bleeding using data derived from FDA Public Summary Documents.
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