 E.3.6. Guidelines for uniformity of patient care: As these studies will be performed at a multiple sites, a series of guidelines will need to be followed by each site. Prior to the initiation of the study, investigators and their study monitor will meet and discuss enrollment criteria, case report forms CRF, see Appendix I and review protocols for the performance of probiotics administration and monitoring of infants. The treatment specifications listed above will serve as an outline for definitive guidelines. Finally, a firm agreement on the definition of HAEC will be established. 