(See Section 9.8.1) Any amendments to the protocol are included in Appendix 16.1.1.1. Subjects who did not meet the inclusion/exclusion criteria could be allowed to enter the study if, following discussion between the Investigator and CRO/Sponsor, written permission was obtained from the CRO/Sponsor. In such instances, written permission was filed at the investigational site and at the CRO/Sponsor.