 - The legal representative is capable of understanding and complying with parameters as outlined in the protocol and able and willing to participate in this study, by signing the informed consent approved by an Independent Ethics Committee IECInstitutional Review Board IRB, after all the aspects of the study that might be relevant for hisher decision to participate are explained and all hisher questions and doubts are elucidated, and prior to the initiation of any screening or study-specific procedures. 