TAXUS IV. In November 2002, we announced our complete 30-day safety data for 1326 patients enrolled in TAXUS IV. TAXUS IV is a pivotal trial designed to collect data to support regulatory filings for U.S. product commercialization. The prospective, randomized, double-blind study is assessing the safety and efficacy of a slow-release formulation for the treatment of de novo coronary lesions. This study is currently in nine-month follow-up. Thirty-day safety data showed an overall favorable MACE rate of 3 percent, although the study remains blinded.

TAXUS V. The TAXUS V trial has received conditional approval from the FDA to enroll patients and will study a higher risk patient population than TAXUS IV, including patients with smaller vessels and longer lesions. The trial – which also includes the use of multiple stents – has a primary endpoint based on nine-month target vessel revascularization and will use the slow-release formulation. This study began enrollment in the first quarter of 2003.