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Results of the economic evaluation in this trial were therefore of limited significance.
Radiographic evaluation in this trial showed significant reductions in progression of erosions, joint space narrowing, and total Sharp score.
The safety evaluation in this trial showed that epoetin alfa increases the incidence of clinically relevant thrombotic events (16.5 vs. 11.5, p = 0.008).
A quality of life evaluation in this trial showed significantly longer time to symptom deterioration in the erlotinib arm for cough, dyspnoea and pain, with associated improvement in physical function and global quality of life.
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All of these severe adverse events were concluded to be not directly associated with the vaccinations, but with cancer progression or other causes by the independent safety evaluation committee in this trial.
The extensive quantitative and qualitative work in our pilot trial has indicated that the planned intervention is effective and acceptable, and our process evaluation in this main trial will focus on (i) mechanisms of change and differential response in patient subgroups, and (ii) the process of implementation of the intervention [ 35].
Since the start of the NELSON study, numerous studies on CT nodule evaluation in the trial have been published.
The physicians decided to select two doses close to the lower and upper ends of the tested dose range from the phase I trials for evaluation in this phase II trial, based on the drug activity-related phase I and preclinical data.
A total of 1696 patients signed informed consent for eligibility evaluation and participation in this trial (Fig. 2).
For the vaccine candidate under evaluation, the experience in this trial suggests that the formulation and lyophilization process could be targeted for improvement.
All researchers involved in the evaluation of this trial were independent from the funders.
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