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Two trials [39], [40] including 173 patients reported on study initiation of dialysis.
On study initiation, we will conduct calibration exercises until sufficient agreement is achieved.
In study 1, animals (male/female ratio of 30/14) were 5 14 years of age on study initiation and ranged from 5.2 to 13.2 kg.
Products were manufactured and supplied by GSK Nutritional Healthcare R&D (Brentford, UK) who monitored and approved chemical, sensorial and microbiological stability of the products used on study initiation and for the duration of the study.
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To evaluate changes in primary end point selection over time, studies were dichotomized into an earlier or later time period based on the year of study initiation and the frequency of time-to-event end points was examined using the Cochran Armitage test for trend.
The few patients who showed deterioration in these outcomes were all on bosentan at the time of study initiation, indicating progression of this severe disease although patients were on PAH-specific therapy.
Data on vascular access were collected at the time of study initiation.
Improvements in WHO functional class and the Global Clinical Impression scales occurred mainly in bosentan-naive patients whereas the rare worsenings occurred in patients already on bosentan prior to study initiation.
The study was previously approved by the Institutional Review Board IRBB of FCM/UNICAMP) of each center and by the National Research Committee prior to study initiation on May 5th 2009 (CEP 027/2009).
Improvements in WHO functional class and the Global Clinical Impression scales occurred mainly in bosentan-naive patients, whereas the rare worsenings occurred in patients already on bosentan prior to study initiation.
Investigators and staff at the 43 academic and private practices participating in CERTAIN completed a comprehensive online and on-site training on the study protocol prior to study initiation.
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