This is an observational (review of records), retrospective (research activity that is performed after the events under the study have occurred) study where data was collected from a medical claims database. The objective of this study was to determine the incidence of cancer among becaplermin users relative to non-users. Adults who were treated with becaplermin between January 1, 2003 and June 30, 2003 were identified in a health insurance claims database. Another group of adults with similar characteristics but who had not been treated with becaplermin were also identified in the database. The medical records of the two groups were followed for an average of 20 months and any diagnosis of cancer was identified and categorized based on type and location of the cancer. Any incidenceof death from cancer was also identified.

This retrospective study did not involve the use of any investigational drug and did not mandate the treatment regimen that the patients received.