18 A double-blind randomized controlled Phase III trial evaluated the efficacy and safety of linaclotide 266 μg (n = 405) versus placebo (n = 395) for 12 weeks.
In short-term double-blind, randomized, controlled, phase III trials in patients with ADHD of all ages, LDX was associated with modest increases in systolic and diastolic BP and pulse rate [ 23– 27].
This was a double-blind, randomized, controlled, phase II clinical trial, two dose study of re-derived, live-attenuated, tetravalent dengue virus (TDEN) vaccine (two formulations) or placebo in subjects 1 50 years of age.
Based on these favorable results, a large (6000 subjects) double-blind, randomized, controlled phase III trial (NCT00779766) is currently ongoing in China to further evaluate the efficacy, immunogenicity, and safety of this vaccine.
The methodological details of the five double-blind, randomized, controlled, phase 3 trials for fingolimod (FREEDOMS and FREEDOMS II), DMF (DEFINE and CONFIRM) and teriflunomide (TEMSO) are described elsewhere [ 9– 13].
Most published studies in trauma patients are retrospective case studies and reports, although an international, double-blind, randomized, controlled, phase II study has been conducted that reported on the efficacy of rFVIIa in reducing the amount of blood products transfused in blunt trauma patients.
Blinded randomized controlled trial.
Design: A prospective, blinded, randomized controlled animal study.
Prospective blinded randomized controlled trial in 1250 hospitals in China.
The study was a double-blind, randomized, controlled, dose escalation phase Ib trial, designed to assess the safety, reactogenicity and immunogenicity of three doses of either 15 or 30 µg of MSP3-LSP adsorbed on aluminum hydroxide in 45 children 12 to 24 months of age randomized into three equal groups.
