 Sirolimus should be re-taken if vomiting occurs within 15 minutes of taking the dose, but not if vomiting occurs more than 15 minutes after taking sirolimus. Patients or their parentsguardians will keep a diary to document the intake of each dose of sirolimus and potential side effects. The patient diary should be reviewed with the patients family at each required clinical study evaluation. In addition, leftover study medication should be collected at each on study evaluation, and drug should be accounted for at this time Appendix V. 