Before initiating this study the Study Protocol, Summary of Product Characteristics (SPC), Patient Information Leaflet and Informed Consent Form, applicable advertising, and any other written information to be given to participants will be reviewed and approved by a properly constituted Institutional Review Board/Independent Ethics Committee (IEC/IRB). A signed and dated statement that all documents submitted for review have been approved by the IEC/IRB will be given to the Sponsor or designee before the study can commence at a site. The membership and the constitution of the IEC/IRB who approved the documents will be also supplied to the Sponsor or designee.