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Secondly, we showed that the presence of an a priori power calculation and the use of restricted randomization, were also significant factors in overall trial quality.
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There was no evidence for socioeconomic inequity in changes in risk factors in the overall trial cohort, or when the population was stratified by baseline CVD risk.
For 140 mg, effects were numerically greater in this subpopulation than in the overall trial population, and as in the overall population, erenumab 140 mg showed numerically greater efficacy than erenumab 70 mg.
For radium-223, also a bone targeting agent, there was also a significant prolongation in time to first SSE in the overall trial population and also in the subgroup of patients receiving bisphosphonates [ 82].
Thus, only 10.5% of patients in the overall trial (71/679) were included in this small substudy, meaning that there is great potential for selection bias.
While the biochemical analysis was carried out in a subsample of the trial population, it is possible that this subset with biochemical measures had better compliance than the rest of the participants, which may have led to overestimation of the differences in plasma homocysteine concentrations achieved in the overall trial population.
For instance, the small subgroup of 366 patients (7%) who were not receiving ACE inhibitors had a 33% reduction in mortality and a 44% decrease in mortality and morbidity, whereas the morbidity and mortality benefit of valsartan observed in the overall trial was no longer significant in patients receiving background ACE inhibitor therapy (relative risk, 0.90; P.10.90
Compared with sorafenib, axitinib significantly improved progression-free survival (PFS) in the overall trial population as well as in the subgroups of patients previously treated with sunitinib or cytokines (Rini et al, 2011).
Randomization was generally successful in distributing subjects equally for demographic variables in the overall trial; however, weight differed significantly across treatment groups (P = 0.049).
In each of those trials, analysis of a dyslipidemic subgroup revealed either significantly greater benefit than in the overall trial cohort (11) or the only actual positive outcome in the study (13, 14).
More serious medical problems weren't seen in the overall trial population.
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