4 results
The primary objective of this study is to compare the acute effects of single doses of methadone (5 and 10 mg) and buprenorphine (0.2 and 0.4 mg) with placebo on driving performance and cognition. Secondary objective is to study the pharmacokinetics…
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
Primary objectives-To assess the concordance between [68Ga]Ga-PentixaFor PET/CT and AVS for identification and/or lateralization of APAs in patients with PA. (Step 1) -To assess non-inferiority in terms of clinical outcomes of [68Ga]Ga-PentixaFor…
Primary objective:1. To evaluate the negative predictive value (NPV) of [68Ga]Ga-PentixaFor (PTF) PET at interim examination (after 6 ± 2 weeks of induction chemotherapy) for progression-free survival (PFS). Secondary objectives:2. To evaluate the…