Subjects who meet the following criteria may be included in the study:
1. Must be willing and able to provide informed consent and be available for the planned follow-up evaluations and radiologic tests; and
2. Must have been randomized, treated and included in the safety population of Protocol BMTI-2006-01 (see Exhibit 13.1).
You may not be if
1\) Subjects that were excluded from the safety analysis in the BMTI-2006-01 study (subjects not listed in Exhibit 13.1). These subjects were consented, but never treated as part of the BMTI-2006-01 protocol.
