A study to extend treatment with JR-141 after completion of Study JR-141-GS31

You may be able to join if

• A subject who participated in the Parent Study (JR-141-GS31) and completed the assessments at Week 105 in Cohort A or Week 53 in Cohort B before being administered the study medication of that respective visit, and in the opinion of the investigator, there are no safety concerns.
• A subject from whom an IRB or IEC-approved written informed consent form (ICF) can be obtained, which is voluntarily signed. If the subject is aged under 18 years (aged under 16 years in the United Kingdom [UK]) at the time of enrollment or willingness to participate in the study cannot be confirmed due to MPS II related intellectual disability, the subject’s legally acceptable representative (e.g., his parents or guardians) may sign the ICF on behalf of the subject. Written informed assent should be obtained from the subject, wherever possible. The principal investigator or his/her designee will retain the original copy of each subject’s signed consent and assent (if applicable) document.
• Female subject of child bearing potential or male subject whose female partner is of child-bearing potential , i.e., fertile, following menarche and until becoming post- menopausal unless permanently sterile, agrees to use a medically accepted, highly effective method of contraception, from the time of signing the ICF.