3 results
The primary objective is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the subject that best…
The objectives of this follow-up/extension study of the VIPES study are:• To assess the efficacy of Viaskin® Peanut after up to 36 months of Epicutaneous Immunotherapy (EPIT) in peanut-allergic subjects.• To evaluate the safety of long-term…
The primary safety endpoint is to evaluate a 30-day major adverse event (MAE) rate, where MAE is a composite of the following device- or procedure-related events: * All-cause mortality* Stroke* Life-threatening bleeding (MVARC scale)* Major vascular…