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This trial adopts the double-blind method.
To overcome this limitation and ensure this trial adopts a fully intention-to-treat design, multiple imputation will be performed for participants with only baseline-data.
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This trial adopted a two-stage Gehan design (Gehan, 1979), enrolling 14 patients in the first stage.
On one hand, this trial adopted oral care protocols without chlorhexidine; on the other hand, the small number of cases and participants increased the possibility that chance accounted for the results.
Because in these patients protection against cardiovascular and all-cause death has thus far been documented in only one trial (9), it might be prudent to preferentially use the antihypertensive drugs that this trial adopted, i.e., a diuretic with the addition of an ACE inhibitor, if needed to achieve BP control.
This trial adopted 65 mg m−2 of irinotecan on days 1 and 8 every 3 weeks schedule in combination with 30 mg m−2 of cisplatin on day 1 and 8, and showed lower overall response rate of 48% and shorter median OS of 9.3 months compared with previous trial of Noda et al (2002), in IP group.
Commonly, a nurse or physiotherapist who has been through a training program related to the trial, adopts this role.
The multi-faceted approach the trial adopts is also rooted in the literature on public health interventions.
The rEECur trial adopts an adaptive multi-arm design with forced selection at a series of pre-specified interim analyses.
The trial adopts a quasi-randomized controlled trial design and involves 2160 high risk individuals selected, via rapid and detailed risk assessments, from about 72,000 farmers aged 35+ in 36 administrative villages randomized into equal intervention and delayed intervention arms.
From a phase II trial of bevacizumab plus irinotecan in patients with malignant astrocytoma, a comparative analysis was performed with several angiogenic factors including CA9 from tumor specimens by Sathornsumette et al. This phase II trial adopted a high dose regimen of bevacizumab, 10 mg/kg/2-wk [ 36].
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Justyna Jupowicz-Kozak
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