The purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies.
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Inclusion Criteria: * Previous participation in a qualifying study. * Male or female at least 18 years of age available for a follow-up period of at least 96 weeks. Exclusion Criteria: * Concurrent treatment in another clinical trial. * Unwilling or unable to be followed for 12 months