Study Designa.

aA total of 97 unique patients participated in the study including study and validation groups.bValidation Groups had no overlapping patients with Study Groups that underwent the same analysis with one exception (please see the next footnote). For Analysis 3, for example, no patients were found in both Study Group 2 and Validation Groups 3 and 4.cEight of the 17 patients in Validation Group 2 were excluded from analysis 5 because they were already included with Study Group 3 leaving 9 patients for the validation and mutual consistency testing (see also text and Table 7).