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Article History

Received: 24 May 2021

Accepted: 27 June 2021

First Online: 7 July 2021

Declarations

:

: The internal review boards of all clinical sites approved this trial, and the protocol was completely reviewed and approved by the Japanese authority, Pharmaceutical and Medical Devices Agency (PMDA). This trial fully complied with the ordinance for medical device GCP (Good Clinical Practice) and was inspected by the PMDA.

: Not applicable.

: TN, ST, MN, TSai, KS, AT, TIka, HE, KI, and TIke report grants from MHLW & AMED, non-financial support such as temporary use of the investigation device, HAL-HN01 from CYBERDYNE. Inc., during the conducting of the study. YKo, YA, TSao, CI, TMae, MM, and KK report grants from MHLW, non-financial support such as temporary use of the investigation device, HAL-HN01 from CYBERDYNE. Inc., during the conducting of the study. YI, SM, MA, MI, TMim, TMiu, JM, and YKa report grants from MHLW & AMED during the conducting of the study. HK and YS report grants from MHLW & AMED during the conducting of the study and personal fees from CYBERDYNE. Inc. unrelated to the submitted work. MSh and TH report grants from MHLW & AMED, personal fees from CYBERDYNE, Inc., during the conducting of the study, and personal fees from CYBERDYNE, Inc. unrelated to the submitted work.