A primary objective of the registry is analysis of comparative safety. The registry may be linked to other registries for the purposes including comparative safety or outcome studies. The program-specific subject identifier number (ID) will be collected for subjects that participate or have participated in a post-market surveillance study. The ID will be used for to ensure the accuracy of safety reporting to regulators by reducing duplicate reports Note that this study has not been submitted to a United States institutional review board. It has been approved by Japanese Authorities.