A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study to Evaluate the Efficacy and Safety of 50 mg/day of DVS SR in Adult Outpatients With Major Depressive Disorder The primary objective is to compare the long-term efficacy and safety of treatment with DVS SR 50 mg/day versus placebo in MDD subjects stabilized on DVS SR, using a randomized withdrawal design. Thi...

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A MULTICENTER, RANDOMIZED, OPEN-LABEL COMPARISON OF THE SAFETY AND EFFICACY OF TIGECYCLINE WITH THAT OF AMPICILLIN-SULBACTAM OR AMOXICILLIN-CLAVULANATE TO TREAT COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS To compare the safety and efficacy of tigecycline with that of the comparator in treating subjects with complicated skin and/or skin structure infection (cSSSI).

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A Phase 2/3, Multicenter, Double-Blind, Randomized, Controlled Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP 2)/Calcium Phosphate Matrix (CPM) in Closed Diaphyseal Tibial Fractures 1. To demonstrate a reduction of time to fracture union based on assessments of radiographs by a central evaluation committee (CEC). 2. To demonstrate acceleration of return to normal function based o...

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A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of rhBMP-2/CPM as an Adjuvant Therapy in Closed Fractures of the Humerus Demonstrate that fracture union is accelerated in subjects with humeral fractures (proximal, shaft) treated with conservative (nonoperative) therapy SOC and a single dose of rhBMP-2/CPM (either 1.0 or...

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A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-of-Care Controlled, Feasibility and Safety Study of rhBMP-2/CPM as an Adjuvant Therapy for Fractures of the Proximal Femur To demonstrate the safety of administering rhBMP-2/CPM (either 1.0 mg/mL or 2.0 mg/mL) as an adjunct to internal fixation in subjects with fractures of the proximal femur. The key safety outcome is th...

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