3 results
Primary Safety Endpoint:Safety will be assessed by incidence and severity of adverse events through 12-weeks (3 month) follow-up. Included in this assessment will be the proportion of subjects with any of the following outcomes between device…
Primary Objective: Therapeutic effect of electrical stimulation. Secondary Objective(s): (i) Side effects of electrical stimulation(ii) Effect on quality of life (iii) Effect of electrical stimulation on inflammatory and histologic parameters.
Primary objective:The primary objective of this study is to assess the time to painful VOC resolution, measured from the first dose of sevuparine given to achievement of crises resolution, as compared to placebo. Secondary objectives: The secondary…