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However if we consider the harder outcome of pain free at 2 h, this placebo effect is only about a fifth of that of verum.
Furthermore randomised trials, in general, include harder outcome.
Recent concerns about bias in self-reported incidence of diarrhea (Schmidt and Cairncross 2009) underline the need to confirm such results in studies with harder outcome measures, such as infection with specific pathogens.
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Follow-up studies are needed to determine whether SAD has clinical significance in terms of harder outcomes such as predicting diabetes mellitus or cardiovascular diseases.
Further studies on the effects of vitamin D supplementation in harder outcomes such as HOMA β-function in these groups should be considered.
While reoperation is a hard outcome, a potential bias should not be forgotten.
Notwithstanding, in the present study, the choice of a hard outcome such as ICU mortality precludes from other threats to observational studies such as detection bias.
The term subclinical AKI represents acute tubular damage in the absence of functional AKI (biomarker positivity without a rise in serum creatinine) and affects hard outcome measures.
Follow-up reporting of hard outcome measures including mortality, hospitalization and morbidity was organized.
Currently there are a few hard outcome evidences regarding a combination statin/fibrate.
Therefore to prevent vascular progression is a reasonable hard outcome and a therapeutic goal in TA.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com