Figure 1.

Patient disposition throughout the extension treatment phases and posttreatment follow-up phase of the trial. Only patients for whom continued therapy was considered clinically appropriate entered each stage subsequent to the initial treatment phase. Most patients who discontinued after entering a subsequent stage did so because of age appropriateness for entry into puberty or parental decision. One patient did not continue due to weight gain, one patient died, and one patient was lost to follow-up due to study site closing.