Finally, because this is a placebo-controlled trial involving children, we have elected to include an interim data analysis to be performed on 12 month on-treatment data (Human Subjects, Section E.). A Data Safety and Monitoring Board comprised of experts in biostatistics, pediatric HIV disease, pediatric endocrinology, and pediatric bone acquisition will be established as per NIH guidelines to monitor study results for safety and efficacy, to establish criteria for early termination of the study in consultation with the Principal and Co-Investigators, and to determine if and when these criteria have been fulfilled.