8. Reduced awareness of hypoglycemia as defined by a Clarke score of 4 or more OR A HYPO score greater than or equal to the 90th percentile (1047) during the screening period; OR Marked glycemic lability characterized by wide swings in blood glucose (BG) despite optimal diabetes therapy and defined by an LI score greater than or equal to the 90th percentile (43 mmol/L2/h·wk-1) during the screening period; OR A composite of a Clarke score of 3 or less and a HYPO score greater than or equal to the 75th percentile (423) and a LI greater than or equal to the 75th percentile (329) during the screening period.