Participant Safety and Ethics

No direct medical benefit is expected for study participants. Product-focused regulation may preserve innovation but can miss risks from cross-border biology, dual use, and living systems. The study has institutional ethics approval and Clinical Trials Registry-India registration. No datasets have yet been generated or analysed because the protocol is ongoing. No formal data safety monitoring committee is established because the pilot is short and does not collect clinical outcomes. The study received ethics approval from the Cantonal Research Ethics Commission for Human Research in December 2022. The study received Kyoto University ethics approval on 4 August 2025 and was registered as UMIN000058696. The study was initially approved on 1 August 2024 and registered at ClinicalTrials.gov as NCT06566456 on 20 August 2024. Consent forms and electronic data are retained for at least 15 years after pilot completion. Safety analyses focus on adverse events and severe adverse events by frequency, severity, MedDRA category, clinical relevance, and association with intervention. All participants receive standardized foundational management including reduced weight-bearing, functional exerc…