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Michael Monine, Corinne Makepeace, Richard Foster, Zdenek Berger: employees of Biogen and may hold stock in the company. Xin Jin: employee of Cytel at the time of development. Russell Chin: employee of Biogen at the time of development.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"This study was performed in accordance with Title 21, United States Code of Federal Regulations (CFR) Parts 50, 54, 56 and 312 Subpart D; the International Council for Harmonisation Guideline on GCP (E6); the European Union Clinical Trial Directive 2001\/20\/EC or Clinical Trial Regulation 536\/2014; and the ethical principles outlined in the Declaration of Helsinki; and\/or, where applicable, the European Directive 2001\/20 in relation to GCP in the conduct of clinical trials on medicinal products for human use and Directive 2005\/28 on GCP for investigational medicinal products for human use. Ethics committee approval of all study documents was obtained prior to the start of the study at the following sites that enrolled participants: EC of Peking University First Hospital, No.\u00a08 Xishiku Street, Xicheng District, Beijing, China; Childrens Hospital of Fudan University, No. 399 Wanyuan Road, Minhang District, Shanghai, China; EC of Beijing Children's Hospital, No. 56 Nanlishi Road, Xicheng District, Beijing, China; EC of Shenzhen Children\u2019s Hospital, No.\u00a07019, Yitian Road, Shenzhen City, Guangdong Province, China; EC of Guangzhou Woman and Children's Medical Center, No.\u00a09 Jinsui Road, Zhujiang New Town, Tianhe District, Guangzhou City, Guangdong Province, China; Medical Ethics Committee of Xiangya Hospital of Central South University, No.\u00a087 Xiangya Road, Kaifu District, Changsha City, Hu'nan Province, China; EC of the First Affiliated Hospital of Fujian Medical University, No. 20 Chazhong Road, Fuzhou City, Fujian Province, China; EC of the First Hospital of Jilin University, No. 1 Xinmin Street, Changchun City, Jilin Province, China; Medical Ethics Committee of the Children's Hospital of Zhejiang University School of Medicine, No. 3333 Binsheng Road, Binjiang District, Hangzhou City, Zhejiang Province, China; EC of Shengjing Hospital of China Medical University, No.\u00a036 Sanhao Street, Heping District, Shengyang City, Liaoning Province, China; Clinical Trial Ethical Committee of West China Second Hospital, Sichuan University, No. 20 San Duan South Renmin Road, Chengdu City, Sichuan Province, China. Informed consent was obtained from all participants or their legally authorized representative in accordance with local practice and regulations.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}