Amendment 1 dated 24 September 2010 included the following major changes to the protocol • The Sponsor Medical Expert and Drug Safety Physician were changed. • The number of investigational sites was increased from approximately 10 to 15. • It was possible that, in some patients, access to an upper extremity vein could be difficult; therefore the option to inject the product through a central venous catheter was added. • The possibility of an assessment of a second lesion was deleted from the protocol because these data were not relevant to the study’s objectives. • Follow-up requirements for truth standard were modified to include histology as appropriate and <6 month confirmation for malignant lesions showing progression of disease on CE-MRI or CE-CT. • The CE-CT and CE-MR image acquisition parameters were modified to be consistent with current clinical practice for examination of the liver. • A statement that training cases were not to be part of the blinded read was added to the off-site assessment methodology section of the protocol to further clarify what was previously stated in the Overall Study Design Description and Statistical Methods. • The number of training cases was reduced from “up to 10” to “up to 4” and the number of efficacy cases was increased to 246 subjects to allow detection of smaller differences and to have higher statistical power for the study.