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Columbia Laboratories, Inc. (CBRX) has received Institutional Review Board (IRB) approval for the first of 19 planned clinical sites for the Company's Phase III PREGNANT (PROCHIEVE(R) Extending GestatioN A New Therapy) study. This randomized, double-blind, placebo-controlled clinical trial will evaluate the effect of PROCHIEVE(R) 8% on reducing the risk of preterm birth in women with a cervical length between 1.0 and 2.0 centimeters as measured by transvaginal ultrasound at mid-pregnancy. The primary endpoint is a reduction in the incidence of preterm birth at less than or equal to 32 weeks gestation vs. placebo.
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