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None of these trials was powered to detect differences in severe hypoglycaemia.
9 10 None of these trials was powered for separate safety and efficacy endpoints.
Although none of the trials was powered to detect differences in efficacy, no evidence was found to suggest that there would be a difference in efficacy of chemotherapy according to treatment administration location.
On balance, the current evidence shows that sevelamer has little effect on serum calcium levels, and is less prone to increase serum calcium levels than calcium salts, although none of these trials was powered to detect a difference.
The rest scored either "low" or unclear" Quality assessment codes: 1 = selection bias; 2 = performance bias; 3 = measurement bias; 4 = attrition bias TBA: Traditional birth attendant MMR: maternal mortality ratio (deaths/100,000 live births) None of the trials was powered to assess maternal mortality, although one trial did show a significant reduction based on small numbers of deaths [ 15].
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No major safety issues have emerged, but conclusive data are lacking, and none of the trials were powered for safety.
Almost all trials were powered for angiographic endpoints, mainly late lumen loss, and scheduled for angiographic surveillance.
With over 4,000 subjects combined, these trials are powered to find smaller effects on outcome and to better explore subgroups.
Sample size and power are additional concerns, as most trials are powered to only detect treatment differences on the overall population level.
While neither of these multi-arm trials is powered for a direct head-to-head comparison of regimens, both will provide comparative efficacy data within the same trial.
Most large clinical trials are powered to find a clinically meaningful difference between treatment and control groups around 80-90% of the time.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com