In accordance with CFR Title 21, Part 312.315, Subpart I (Expanded Access to Investigational Drugs for Treatment Use for Intermediate-size Populations) this study will be submitted to the MT-2724 IND (# 121918) for FDA review and approval. Prior to enrolling a subject in this study each investigator who elects to participate in this study is responsible to (i) obtain local institutional review board (IRB) approval for this study and its associated informed consent form, (ii) review each potential study candidate's eligibility with the sponsor and (iii) obtain each potential subject's signed, local IRB approved informed consent form for this study prior to performing any study related activities.