4 results
(this text is taken from the protocol, see protocol for the detailed version)The main objective of the study is to gain insight in the underlying mechanism of tinnitus suppression. This objective will be achieved by comparing the suppressive effect…
Cohort 1:A data monitoring committee (DMC) will evaluate all available safety data from the study. The first 2 meetings for safety surveillance will occur after 50 and 100 subjects complete or discontinue from the Blinded Induction Phase from Cohort…
The primary objectives of this study are as follows:* To assess the safety and tolerability of escalating single and multiple doses of GS-5745 in subjects with moderate to severe ulcerativecolitis (UC) as assessed by adverse events (AEs), and…
Primary * To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR) in patients with 1 of the following relapsed or refractory lymphoma or leukemia subtypes: mantle cell lymphoma (MCL), follicular lymphoma (FL), or…