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33 However, we acknowledge that this formal rule is insufficient to prevent bias consequent on stopping early 34 and we will additionally require a large number of outcome events and considerations of clinical significance over and above the statistical boundary before early stopping for benefit is contemplated.
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Should important differences be observed between intervention and control arms, we will additionally conduct covariate-adjusted generalized linear mixed models to assess the degree to which these differences alter our measures of association.
After two years we will additionally measure lung function and exercise capacity again.
We will additionally test whether EED, diarrhea, and decreased appetite mediate the association between mycotoxins and stunting [ 43].
We will additionally characterise variation in treatments and outcomes by patient characteristics, hospital, region and study year.
We will additionally highlight points of contact between the biology and the pathophysiology that has been proposed to cause a clinical disorder of scene construction – spatial hemineglect.
We will additionally, look at the use of frailty definitions and profiles across different settings and the impact on disability assessments.
88 We will additionally measure En. vermicularis, Taenia spp, Hymenolepis spp, and Strongyloides stercoralis in all stool samples.
We will additionally report risk ratios for dichotomous outcomes as recommended by CONSORT.
We will additionally adjust for the stratified randomization when calculating the relative risk.
We will additionally consider a dichotomised indicator of treatment response defined as a 50% reduction in crying time.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com