4 results
The primary objective of the study is to provide evidence that the use of a sealing surgical patch applied to the surgical field following parotidectomy is non-inferior in efficacy to the common practice of CSD insertion by wound closure, measured…
The primary efficacy variable is if the TachoSil application was feasible. A feasible application implies that the entire TachoSil adhere, TachoSil covers at least 1 cm beyond the margins of the anastomosis line and if more TachoSil sponges are used…
PRIMARY OBJECTIVE To characterize the pharmacokinetics (PK) of single doses of solriamfetolin pediatric subjects with narcolepsy.SECONDARY OBJECTIVE To assess the safety and tolerability of single doses of solriamfetol inpediatric subjects with…
The primary objective of Arm 1 is to evaluate the overall response rate (ORR) as determined by an independent radiology review committee (IRC) and measured by the proportion of patients with best overall confirmed response of complete response (CR)…