Evidence of ischemia or heart block on screening electrocardiogram (greater than type I-second degree heart block, left bundle branch block, or ST-T wave changes in 2 or more contiguous leads).
Acute hospitalizations including surgery in the past 6 months
Chronic use of non-steroidal anti-inflammatory or narcotic medications
Women who are pregnant or nursing, or wish to become pregnant and/or who can not agree or tolerate two forms of birth control during the study period:
Acceptable birth control methods for use in this study are:
hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
intrauterine device (IUD)
abstinence (no sex)
Significant concomitant medical illnesses (cancer, chronic active immunological conditions, etc.)
