The PI will hold the sealed randomization list for use if necessary in case of adverse events that may be seen in the study by the DSMB. Otherwise the list will not be unblinded until completion of the study, and complete entry and editing of relevant data before initiation of the analyses. The entire data set will be locked prior to unblinding. If the intervention assignment is un-blinded due to any reason, the DSMB will be notified within 24 hours.