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Thus the trial mandated 3 months of neoadjuvant 5FU/LV in the preoperative arm, followed by postoperative adjuvant weekly 5FU/LV.
69 A total of 21 105 patients with moderate to high risk non-valvular atrial fibrillation were randomized, and the trial mandated a dose reduction (by half) for patients with any of the following: creatinine clearance 30-50 mL/min; weight ≤60 kg; or concomitant use of verapamil, quinidine, or dronedarone.
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The trial mandates assessment of disease activity with monthly visits in the T2T intervention group and up to monthly treatment acceleration until disease control is achieved.
Protocols for these four of five pivotal phase 3 trials mandated that patients receiving a stable immunomodulator regimen at baseline would continue such use throughout study participation.
Their prevalence in surgical trials mandates an approach to developing valid evidence for operations that directly addresses these unique problems.
The final version was installed as a document provided to trial sites and its use for all trial participants mandated in the trial manual.
Kim et al. [30] subsequently published a trial in 2011 that was quite unique in that it is a prospective trial that mandated biopsies in patients with pre-treated lung cancer.
The shark cartilage clinical trial was mandated by Congress and was sponsored by the National Cancer Institute.
Currently an ongoing phase III trial with mandated growth factor support is underway assessing the efficacy and safety of selumetinib and docetaxel in advanced or metastatic KRAS mutant NSCLC in the second line and beyond (NCT01933932).
Neither trial protocol mandated measurement of serum CA 19-9 but levels were typically measured both prior to (pretreatment level) and following (restaging level) induction therapy.
Heart rate in PARADIGM-HF is similar to most other studies except SHIFT (Systolic Heart Failure Treatment with the I f Inhibitor Ivabradine Trial, which mandated a heart rate of ≥70 bpm for inclusion) and SOLVD-T.
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