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(From Fair Disclosure Wire)
OPERATOR: Good morning, ladies and gentlemen. Thank you for standing by. Welcome to the Vasogen conference call. [OPERATOR INSTRUCTIONS] The company will be making forward-looking statements during this call. These involve risks and uncertainties such that actual results may be different. The company assumes no obligation to update any forward-looking statements. The disclaimer on forward-looking statements set out under legal notice at Vasogen's website at www.vasogen.com, also applies to forward-looking statements made during this call. I would now like to advise everyone that this conference call is being recorded. And we will now turn the conference over to Mr. David Elsley, President and Chief Executive Officer. Please go ahead, sir. DAVID ELSLEY, PRESIDENT, CEO AND DIRECTOR, VASOGEN INC.: Thanks, operator, and good morning, everyone in the West. As we are doing this call from Barcelona, Spain, it is already afternoon here. And joining me on the call today is Dr. Jay Kleiman, Chief Medical Officer and Head of Cardiovascular Development at Vasogen. And from our Toronto office, Paul Van Damme, our Chief Financial Officer is also participating in today's call. Before I get started, I would like to draw your attention to our forward-looking statement notice, which the operator has already reviewed in brief. In today's call, we will be focusing on the new results from our ACCLAIM heart failure trial, results which we believe form a strong foundation for the commercial development of Celacade. The results, based on the full data set from the ACCLAIM study were presented over the past weekend at the World Congress of Cardiology in Barcelona by Dr. Torre-Amione, the principal investigator for the U.S. of the ACCLAIM trial, and a leading expert on the role of inflammation in heart failure. The World Congress of Cardiology is the largest European medical meeting, with more than 25,000 cardiologists and other disciplines in attendance, and has been an excellent venue at which to disseminate the new findings from the ACCLAIM trial. First, I'll provide some background on chronic heart failure. This condition, as many of you are aware, affects a large number of people. In fact, it afflicts 11 million people in North America and Europe. While existing therapies are focused on the symptoms of heart failure, it is now known that chronic inflammation contributes to the progression of this syndrome. Celacade targets this underlying pathology. Heart failure is progressive, can become irreversible and results in more than 300,000 deaths each year in the United States alone. And about half of all heart failure patients will die within five years of diagnosis. The annual cost associated with this condition exceeds $25 billion in the United States alone, and the primary driver of this cost is recurring hospitalizations. Heart failure, in fact, remains the leading cause of hospitalization for people over the age of 65. ACCLAIM was an international pivotal Phase III study conducted in 2,400 patients at 175 centers in seven countries. The study was designed as an event rate driven trial, and concluded when 823 primary outcome events, being deaths or cardiovascular hospitalizations, had occurred. ACCLAIM enrolled Class II, III and IV heart failure patients with left-ventricular ejection fractions of less than 30%. And the primary outcome was the composite of death or first cardiovascular hospitalization. All patients in this study were also receiving standard of care therapy or optimal therapeutic intervention for their heart failure. Dr. James Young, Chairman of the Division of Medicine of the Cleveland Clinic, is the global principal investigator for the ACCLAIM trial, and is widely recognized as an opinion leader in heart failure, and has been involved in the development of many new therapeutic entrants to address this serious problem. Dr. Young headed an international steering committee representing thought leaders in heart failure from around the world. And with that as an introduction, I will now turn the call over to Dr. Jay Kleiman to…