Michael D. Lesem, the publication’s business lead author, a principal investigator for the Phase 3 trial and Medical Director at Claghorn-Lesem Analysis Clinic, Houston, Texas. The primary efficacy end-point of the study was change from baseline in PANSS Excited Component score , measured at two hours following the first dosage of study medication. Results of the study demonstrated that AZ-004 offered a statistically significant decrease in agitation compared to placebo, as assessed by the main element and primary secondary end-points. We are pleased to have this Phase 3 clinical trial published in a peer-reviewed journal of the caliber of the British Journal of Psychiatry, stated Dr. James V. Cassella, Alexza Senior Vice President, Development and Research.S. In of this yr and the submission of the MAA in Europe in the 3rd quarter July.The same volume of aluminum hydroxide in buffered saline without antigen was used as a placebo. Both the vaccine and placebo had been prepared in a service that was compliant with Good Manufacturing Procedures and were examined by the National Institutes for Food and Drug Control before the start of study. Study Design and Participants This randomized, double-blind, placebo-controlled clinical study was created by the Institute of Medical Biology, the guts for Medication Evaluation in the Condition Food and Medication Administration, and the Center for Disease Control and Avoidance of the Guangxi Zhuang Autonomous Region .