Pseudonymised data from the subjects' medical records will be abstracted by local site study staff and entered at the site into the secured pass-word protected electronic data capture (EDC) system. No patient-identifying information will be available to non-site staff; (i.e., representatives of the SCC and the study sponsor). Over the course of the study, as data are entered, the case status page within the EDC system will automatically update the study disposition of each case. As the data will be automatically quality controlled at the point of data entry into the EDC system on the basis of programmed validation rules for each of the study variables, quality control and query resolution can be managed remotely. Therefore, site data monitoring visits by the SCC are not envisioned. No patient-identifying information will be entered into the EDC system; as such, neither the SCC nor the study sponsor will be able to identify subjects as actual patients.