IRB approval was extended another six months, to September 15, 2004, or until the first Data Safety Monitoring Board (DSMB) report is available. Approval is conditional upon review of the data on an ongoing basis by the DSMB. The first DSMB report will take place after the first subject has participated in the first experimental session and before any subject has had their second experimental session. This first DSMB meeting will most likely take place in late April or early May. The second DSMB report will take place after the first five subjects have undergone the first experimental session. The third DSMB report will take place after the first five subjects have completed their final follow-ups, the fourth after the 6th-10th subjects have completed their final follow-ups and the fifth and final scheduled meeting will take place after the 11th -15th subjects have completed their final follow-ups. Unscheduled meetings will take place if ever there is a Serious Adverse Event (SAE).