Two hundred and twenty-five healthy Australian children aged 12 42 months were enrolled and randomized in a 3 2 ratio to receive CAIV-T blended and filled either at Medeva or at Aviron-PA.
Budesonide 800 μg bd, budesonide 200 μg bd, or theophylline (Theo-Dur® 300 mg bd was given double-blind, double-dummy, and randomized, in a parallel group design for 9 months; when therapy was stopped patients were followed for an additional 3 months.
Patients will be stratified by site and randomized in a ratio of 1 1 into the two groups.
The second of these two prospective studies entailed 34 patients who were stratified based on the etiology of AKI and randomized in a paired fashion [ 29].
In study B, subjects aged 2 10 years were recruited at Shirdi Saibaba Rural Hospital, Vadu Budruk, India, and randomized in a 1 1 ratio to receive 1 dose of either PsA-TT or PsACWY.
One hundred and fifty patients with COPD and chronic bronchitis for at least 12 months will be recruited into the study and randomized in a 1 1 ratio to receive either roflumilast or placebo.
Patients were stratified according to regions and randomized in a 2 1 ratio (ferric carboxymaltose:placebo). Ferric carboxymaltose solution (Ferinject®, Vifor International) for parenteral application, 50 mg iron/mL iron.
In brief, subjects aged 2 29 years were recruited, stratified into 3 age groups of 2 10, 11 17, and 18 29 years, and randomized in a 2 1 ratio to receive either 1 dose of PsA-TT or a licensed PsACWY vaccine (Mencevax ACWY, GSK).
Since only post-hoc/retrospective data analyses were positive in selected patient subsets, it remains possible that these trials might have demonstrated superiority and thus supported approval if better prognosis subjects had been identified prospectively and randomized in a separate stratum.
This Phase III study is looking at patients with pretreated advanced NSCLC (diagnosis greater than 6 months prior) and randomizing in a 1 1 fashion with docetaxel and the ganetespib and docetaxel combination (NCT01798485).
From January 2013 to September 2013, 177 patients diagnosed with mild-moderate ED (IIEF-EF < 26) were enrolled in this multicenter, single-blinded, placebo-controlled study and randomized in Group A (Tradamix, n = 87) and Group B (placebo, n = 90).
