* Quality assurance plan was implemented by site monitoring, including data validation and registry procedures and Source data verification to assess the accuracy, completeness by comparing the data to external data sources (medical records and paper case report forms).
* Data dictionary contains the registry, including the source of the variable, coding information (MedDRA ver12.0), and normal ranges.
* Statistical analysis were performed using SAS® Version 9.2, SAS institute, Cary, NC, USA
