All serious adverse experience must be reported to the University of Texas Health Science IRB using the serious adverse experience facsimile or email or by telephone/email as soon as the serious adverse experience is discovered, and within 24 hours after the Investigator recognizes or classifies the event as a serious adverse experience. A brief description of the event must be provided at the time of the initial serious adverse experience report. The initial serious adverse experience report should be followed up by additional information using the serious adverse experience within 48 hours. The reports should identify the patient by their unique patient number instead of names. The completed serious adverse experience Form will be used by the investigators in regulatory filings. The investigator is responsible for continuing to report to the University of Texas Health Science IRB any new or relevant follow-up information obtained concerning the serious adverse experience. The results of any additional assessments conducted must be also reported to the University of Texas Health Science IRB.