 E.3.7. Monitoring: Each site will specify a study monitor who will be responsible for data collection and monitoring infants for protocol compliance and the development of adverse events AEs, see Appendix II. The study monitor will be responsible for data transmission for data collection and analysis. Heshe will also be responsible for informing the Investigator and the respective IRBs of adverse events. When there is an adverse event which is believed to have a relation to the performance of this study or a significant adverse event SAE, they will be responsible for reporting this within 48 hours to both their IRB, and all other investigators. In a similar time, a report to the FDA will be done. Yearly reporting of all AEs to each IRB and the FDA will be done. 