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For the control phase of the study, participants were simply asked to continue with their usual diets.
In the control phase of the study, a single home visit for data collection purposes will be conducted by a project officer approximately 8 days post-discharge.
Using a 5% significance level two-tailed testing of differences between two independent groups (usual care and intervention), a sample of 100 patients from the intervention and 100 patients from the control phase of the study would have 80% power to detect group differences between patients under these two experimental conditions of 0.40 SDs for the primary outcome measure.
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Arterial stiffness, lipid profiles, HOMA and adiponectin were not assessed during the placebo controlled phase of the study.
A research assistant who was blinded to supervisors' group (intervention or control) and phase of the study (pre-post-intervention) coded all the written comments.
There were no significant differences found between experimental and control at any phase of the study, at baseline, 6 months, or 12 months.
The purpose of this work was to investigate whether the data previously obtained could be confirmed also in the group of 192 subjects that served as controls in first phase of the study and received the intervention in the second phase of the study.
The target controlled infusion (TCI) phase of the study explored the suitability of Org 25435 for maintenance of anaesthesia.
The results for the placebo controlled double-blind phase of the study are shown in fig 1. Tender and swollen joint counts, patient global assessments and DAS28 scores were all significantly lower in the treatment arm by 8 and 16 weeks.
The purpose of this work was to investigate whether the data previously obtained could be observed also in the group of subjects that served as controls in the first phase of the study and received the intervention subsequently.
The purpose of this work, that represents a secondary outcome of the trial protocol, was to investigate whether the results previously obtained [10, 11] could be confirmed also in the group of subjects that served as controls in the first phase of the study and received the intervention subsequently.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com