A phase III double-blind, placebo-controlled, randomized withdrawal trial of 5‑aminolevulinic acid hydrochloride with sodium ferrous citrate for efficacy and safety in patients diagnosed as Leigh syndrome

• Akira Ohtake ,

  Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Supervision, Writing – review & editing

  ¶☯ These three authors contribute equally..

  Affiliations Department of Pediatrics, Saitama Medical University Hospital, Moroyama, Japan, Department of Clinical Genomics, Saitama Medical University Hospital, Moroyama, Japan

  https://orcid.org/0000-0003-1147-3113

  ⨯
• Yuichi Abe ,

  Roles Conceptualization, Formal analysis, Investigation, Methodology, Writing – review & editing

  Current Address: Division of Neurology, National Center for Child Health and Development, Setagaya, Tokyo, Japan.

  ¶☯ These three authors contribute equally..

  Affiliation Department of Pediatrics, Saitama Medical University Hospital, Moroyama, Japan

  https://orcid.org/0000-0003-3373-0029

  ⨯
• Kei Murayama ,

  Roles Conceptualization, Data curation, Investigation, Methodology, Project administration, Supervision, Writing – review & editing

  Current Address: Department of Pediatrics, Juntendo University, Bunkyo, Tokyo, Japan.; Diagnostics and Therapeutic of Intractable Diseases, Intractable Disease Research Center, Graduate School of Medicine, Juntendo University, Bunkyo, Tokyo, Japan.

  ¶☯ These three authors contribute equally..

  Affiliation Department of Metabolism, Chiba Children’s Hospital, Chiba, Japan

  ⨯
• Hideaki Shiraishi,

  Roles Data curation, Investigation, Writing – review & editing

  Affiliations Department of Pediatrics, Hokkaido University Hospital, Sapporo, Japan, Department of Pediatrics, Dokkyo Medical University, Mibu, Japan

  ⨯
• Hitoshi Osaka,

  Roles Data curation, Investigation, Writing – review & editing

  Affiliation Department of Pediatrics, Jichi Medical University, Shimotsuke, Japan

  ⨯
• Satoko Kumada,

  Roles Data curation, Investigation, Writing – review & editing

  Affiliation Department of Neuro Pediatrics, Tokyo Metropolitan Neurological Hospital, Fuchu, Japan

  ⨯
• Tetsuya Ito,

  Roles Data curation, Investigation, Writing – review & editing

  Affiliation Department of Pediatrics, Fujita Health University Hospital, Toyoake, Japan

  ⨯
• Hidehito Kondo,

  Roles Data curation, Writing – review & editing

  Affiliation Department of Pediatrics, Japanese Red Cross Society Kyoto Daiichi Hospital, Kyoto, Japan

  ⨯
• Yusuke Hamada,

  Roles Data curation, Investigation, Writing – review & editing

  Current Address: Department of Pediatrics, Suita Municipal Hospital, Suita, Japan.

  Affiliation Department of Pediatrics, Toyonaka Municipal Hospital, Toyonaka, Japan

  ⨯
• Sayaka Suzuki-Ajihara,

  Roles Data curation, Investigation

  Affiliations Department of Pediatrics, Saitama Medical University Hospital, Moroyama, Japan, Department of Clinical Genomics, Saitama Medical University Hospital, Moroyama, Japan

  ⨯
• Masato Arao,

  Roles Investigation

  Affiliation Department of Pediatrics, Saitama Medical University Hospital, Moroyama, Japan

  ⨯
• Yuki Ueda,

  Roles Data curation, Writing – review & editing

  Affiliation Department of Pediatrics, Hokkaido University Hospital, Sapporo, Japan

  ⨯
• Kohei Nagai,

  Roles Data curation, Investigation

  Affiliation Department of Pediatrics, Jichi Medical University, Shimotsuke, Japan

  ⨯
• Keiko Ichimoto,

  Roles Data curation, Investigation

  Affiliation Department of Metabolism, Chiba Children’s Hospital, Chiba, Japan

  ⨯
• Ayako Matsunaga,

  Roles Data curation, Investigation

  Current Address: Department of Pediatrics, St. Marianna University School of Medicine, Kawasaki, Japan.

  Affiliation Department of Metabolism, Chiba Children’s Hospital, Chiba, Japan

  ⨯
• Hirofumi Kashii,

  Roles Data curation, Investigation, Writing – review & editing

  Affiliation Department of Neuro Pediatrics, Tokyo Metropolitan Neurological Hospital, Fuchu, Japan

  ⨯
• Yoko Nakajima,

  Roles Data curation, Investigation, Writing – review & editing

  Affiliation Department of Pediatrics, Fujita Health University Hospital, Toyoake, Japan

  ⨯
• Hitoshi Nakagawa,

  Roles Conceptualization, Formal analysis, Investigation, Methodology, Visualization, Writing – original draft, Writing – review & editing

  Affiliation Department of Clinical Development, SBI Pharmaceuticals, Minato, Tokyo, Japan

  https://orcid.org/0009-0009-6568-9391

  ⨯
• Shunichi Kurose,

  Roles Validation, Writing – review & editing

  Affiliation Department of Clinical Development, SBI Pharmaceuticals, Minato, Tokyo, Japan

  ⨯
• Kaori Fukuda,

  Roles Formal analysis, Validation, Writing – review & editing

  Affiliation Department of Clinical Development, SBI Pharmaceuticals, Minato, Tokyo, Japan

  ⨯
• Kiwamu Takahashi,

  Roles Conceptualization, Methodology, Project administration, Writing – review & editing

  Affiliation Department of Research and Development, SBI Pharmaceuticals, Minato, Tokyo, Japan

  ⨯
• Mitsugu Yamauchi,

  Roles Conceptualization, Funding acquisition, Methodology, Project administration, Writing – review & editing

  Affiliation Department of Clinical Development, SBI Pharmaceuticals, Minato, Tokyo, Japan

  ⨯
•  [ ... ],
• Motowo Nakajima

  Roles Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Supervision, Writing – original draft, Writing – review & editing

  * E-mail: motnakaj@sbigroup.co.jp

  Affiliation Department of Clinical Development, SBI Pharmaceuticals, Minato, Tokyo, Japan

  https://orcid.org/0000-0001-7687-6365

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