Serious Adverse events is an adverse event which becomes serious and could endanger the life of subjects, cause prolonged hospitalization and disability to conduct normal life. The Data Safety and Monitoring Board will be recorded in Severe Adverse Event form and reported to Principal Investigator, sponsors, Ethic Committee, Regulatory and Data Safety and Monitoring Board within 24 hours. Severe Adverse Event subjects will be treated in Atambua Hospital until recover completely. All expenses will be paid by sponsor. Complete Severe Adverse Event report will be distributed within one month after the occurrence of Severe Adverse Event.