4 results
Primary: • Demonstrate superior efficacy (increased progression-free survival [PFS]) of MEK162 vs. physician*s choice of selected chemotherapies (liposomal doxorubicin, paclitaxel and topotecan)Key Secondary: • Demonstrate superior efficacy (…
To compare the severity of retinopathy of prematurity (ROP) among treated infants with an untreated control population, matched for GA at birth while confirming the dose of rhIGF 1/rhIGFBP-3 is safe and efficacious.
The primary objective of this study is to assess the effect of OHB-607 on reducing the burden of CLD, as indicated by a reduction in the incidence of severe BPD (as defined by the modified NICHD severity grading) at 36 weeks (±3 days) PMA, or death…
Primary ObjectiveTo generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints Secondary…