Additional file 1: of Assessing the efficacy and safety of magnesium sulfate for management of autonomic nervous system dysregulation in Vietnamese children with severe hand foot and mouth disease

Appendix A. Details of the general study methodology for the clinical trial. Appendix A.1. Trial study_Screening and enrolment. Appendix A.2. Trial study_Sampling. Appendix A.3. Trial study_ Initiation of study medication, safety monitoring, dose adjustment. Appendix A.4. Trial study_Emergency management. Appendix A.5. Trial study_Emergency unblinding procedure. Appendix A.6. Trial study_Additional study definitions. Appendix A.7. Trial study_Definitions for Clinical Adverse Event Grading in the trial (modified from CTCAE Version 4.03). Appendix A.8. Trial study_Definitions for Laboratory Adverse Event Grading in the trial (modified from CTCAE Version 4.03). Appendix B. Additional methods for the observational cohort study. Appendix B.1. Cohort study_Identification of study subjects. Appendix B.2. Cohort study_Data collection and data management. Appendix B.3. Cohort study_Statistical analysis. (ZIP 257 kb)