Haigo, Hisamitsu https://orcid.org/0009-0001-2306-4942
Matsuda, Kenji
Shikano, Mayumi https://orcid.org/0000-0001-9199-540X
Article History
Received: 27 August 2024
Accepted: 27 March 2025
First Online: 14 April 2025
Declarations
:
: Our research is based on the publicized drug approval review report by the Japanese health authority. The clinical studies included in the review report were conducted in compliance with the ICH GCP and were already approved by the local ethics committee or institutional review board (IRB). Therefore, informed consent was obtained from parents or regal guardians of all pediatric subjects under the age of 16, and those are guaranteed by inspection of health authorities of Japan or other countries.
: Not applicable.
: The authors declare no competing interests.