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This pivotal study suggests that both MTHFR and MTRR gene variants may influence the response to treatment with vitamin B in migraineurs.
This pivotal study publication reported on two parallel, multicenter, randomized, double-blind, Phase III clinical trials.
Twenty-one Caucasian women and 11 Caucasian men participated in the open label extension of this pivotal study.
17 This pivotal study was designed and conducted at a time when standard therapy for metastatic RCC was in transition.
The results of this pivotal study revealed that concurrent chemoradiation therapy significantly improve the local control, disease-free and overall survival rates [ 1].
This pivotal study, designed to demonstrate a reduction in risk of morbidity/mortality events, is fully enrolled with 1,156 patients (the largest PAH trial so far).
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In line with this, the pivotal study by Rivers et al. [1] showed that massive fluid administration during the first 6 h of resuscitation of patients with severe sepsis and septic shock was associated with improved outcome.
Finally, data from the ENTERIC study were not included, and we believe that this study is the pivotal study in the area [ 21].
So far, the studies have shown that taliglucerase alfa is very effective, and this effectiveness also covers the extension period of the pivotal study, up to 24 months.
This study was conducted as an addendum to the pivotal study for the approval of the Juvéderm family of products in the U.S.
This compares favorably with the 11% grade 3 4 myocardial dysfunction found in the pivotal study with 3-weekly paclitaxel [ 6].
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