Although BOTOX® was first approved by the FDA in 1989, clinical trial investigations began over 20 years ago. BOTOX® has now been approved in over 70 countries for a variety of uses, with millions of people worldwide having benefited from BOTOX® treatments. In all, the BOTOX® product has been used safely and effectively in over 7 million treatments for approximately 2 1/2 million people since its first approval in the U.S. The FDA approved BOTOX® Cosmetic on April 12, 2002 specifically for the temporary improvement of frown lines in adult patients. The FDA approval of BOTOX® Cosmetic immediately ignited worldwide news coverage. Highlights in the first year of launch included: -- Cosmetic use is now approved in 21 countries under the names BOTOX®, BOTOX® Cosmetic and VISTABEL®; -- More than 500,000 men and women were treated with BOTOX® Cosmetic in 2002, making it the #1 cosmetic treatment in America; -- More than 10 million men and women were identified to be potential candidates for BOTOX® Cosmetic treatments (Gallup Facial Appearance Improvement Survey, 2002); -- More than 7,000 broadcast stories and 6,500 articles on BOTOX®(R)/BOTOX® Cosmetic were done in the U.S.; -- Approximately 4,500 aesthetic-specialty physicians were registered on the BOTOX® Cosmetic Physicians' Network, providing BOTOX® Cosmetic treatments to residents of all 50 states; and -- Over 600,000 searches for BOTOX® Cosmetic physicians were performed on www.BOTOX®cosmetic.com. BOTOX® Cosmetic is approved and marketed specifically for temporary improvement of frown lines in men and women aged 18 to 65. It's a natural, purified protein, which in very low doses relaxes the overactive muscles that cause frown lines to form. The effects last about four months, after which lines gradually revert to their pre-treatment appearance. The most common side effects of BOTOX® Cosmetic, if any occur, may include headache, respiratory infection, flu syndrome, temporary eyelid droop and nausea.