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69 subjects are intended to be randomized at a 2 1 (treatment arm: control arm) ratio using a blinded blocked randomization scheme separated by site.
Eligible patients (enrollment target, n = 170) will be randomized at a 1 1 ratio to receive 4 cycles of carboplatin (area under the curve, 6 on day 1) plus nab-paclitaxel (100 mg/m2 on days 1, 8, and 15) administered every 3 weeks either without (arm A) or with (arm B) nintedanib (150 mg twice daily), to be followed in arm B by single-agent administration of nintedanib (150 mg twice daily).
Patients will be randomized at a 2 1 ratio to the treatment arm.
The subjects needed to be randomized at a ratio of 1 1 1 1.
An intended sixty nine subjects will be randomized at a 2 1 (treatment arm:control arm) ratio.
Four hundred patients were to be randomized at a 3 1 ratio; 300 (225 MEC, 75 HEC) to NEPA and 100 (75 MEC, 25 HEC) to APR + PALO.
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Eligible children are randomized at a 1 1 ratio by computerized central randomization using stratified blocked randomization with variable block sizes to maintain balance across important prognostic factors.
Patients were randomized at a ratio of 1 1 using a web-based central randomization system.
Eligible patients (enrollment N = 1242) are randomized at a 1 1 ratio to receive either docetaxel (75 mg/m2) plus ramucirumab (10 mg/kg) (Arm A) or docetaxel (75 mg/m2) plus placebo (Arm B).
From August 17 19, 2009, a total of 326 children and 300 adults were randomized at a 4∶1 ratio to receive H1N1 LAIV or placebo (Figure 1).
These subjects were randomized at a 1∶1 ratio to receive one dose of either TIV (Fluzone®, Aventis-Pasteur) or LAIV (FluMist®, MedImmune).
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