Safety Monitoring Committee: An independent Safety Monitoring Committee consisting of 2 rheumatologists, 1 epidemiologist/ biostatistician, and 2 endocrinologists, not participating as investigators will be established. The committee will meet every 12 months, or at any time if an unusual problem occurs, to review all unacceptable events as defined by the investigators during the planning phase, and determine whether they may be attributable to the treatment studied. The study will be stopped by the Safety Monitoring Committee if the number of unacceptable events reaches the stopping criterion. The committee will also review the interim analysis, with authority to stop the study if a significant difference (P < 0.01) was detected.