All "source document" data collected from the study visits, except data that would indicate randomization assignment, will be maintained in a secure location within the Children's Hospital of Eastern Ontario. The investigator will verify that all data entries in the CRF are accurate and correct. Data collection is the responsibility of the research staff at the site under the supervision of the Principal Investigator. During the study the investigator will maintain complete and accurate documentation for the study and keep all original source documents. All adverse events will be graded, assessed by severity and causality and reviewed by the site investigator. Original subject records (source documents) will be reviewed during the course of the monitoring to verify the accuracy of the CRF's. This review will be conducted according to the peer monitoring plan. The Investigator(s) institutions(s) will permit trial-related monitoring, audits, REB(s) review and regulatory inspections(s) by providing direct access to source data and documentation. The medical (hospital/practice) records for each patient should contain information to provide a means by which study data can be verified. Patient information collected electronically will be available for review when the study site is monitored or audited. Entry of these data in SPSS will be performed primarily by the PhD student, but partly by the co-Principal investigators. Subjects will be assigned a code number to maintain blinding to data management staff, with the corresponding list of names associated with subject codes kept by the pharmacist in a secure filing cabinet. Databases will be stored on a secure server, with nightly backup.