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Cizza, G., Piaggi, P., Rother, K. I. & Csako, G. & Sleep Extension Study, G. Hawthorne effect with transient behavioral and biochemical changes in a randomized controlled sleep extension trial of chronically short-sleeping obese adults: implications for the design and interpretation of clinical studies.
HORIZON: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age-related macular degeneration.
We have implemented an open-label, long-term extension trial of this study to continue evaluating the safety of duloxetine.
This open-label extension trial of tocilizumab demonstrated a sustained good efficacy and a generally good safety profile over 5 years.
In an 82-week, open-label extension trial of exenatide in 314 patients, significant improvements in HDL cholesterol, triglycerides, and DBP were seen with trends for improvement in total cholesterol, LDL cholesterol, and SBP.
Recently, in a 1-year extension trial of exenatide once weekly, weight change was shown to be significantly correlated with reductions in DBP, LDL cholesterol, and total cholesterol but not with triglycerides and SBP (21).
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In the extension trials of denosumab that have now been reported out through 8 years, there is a continual increase in BMD.
In 151 patients followed in open-label extension trials of exenatide for 3.5 years and stratified by weight change quartile, those losing the most weight had the greatest improvements in triglycerides, HDL cholesterol, and blood pressure.
For each group, change in weight (kg) over time (weeks) had begun to plateau by the study endpoint, a pattern echoed by the long-term extension trials of exenatide [ 23].
Of the 710 patients who completed double-blind treatment, 561 patients (79%) were assessed for eligibility in the long-term open-label extension study, and 560 patients were treated; one patient was not entered into the extension trial because of a positive test for cannabinoids on the drugs of abuse screen.
Of these 15 patients, 8 received treatment in the extension trial and 3 of these had a tumour assessment performed at week 16.
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