5 results
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.
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 (…
Primary- To determine the validity of home-based self-monitoring of VC in patients with MND.Secondary- To determine the reliability of home-based self-monitoring of VC in patients with MND.- To evaluate the feasibility of 4-weekly home-based self-…
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…