Ethics approval
CNPD
All procedures performed in this study involving human participants were in accordance with the ethical standards of the Portuguese INFARMED and with the 1964 Helsinki Declaration or comparable ethical standards. iBone Therapies (European Databank on Medical Devices, EUDAMED, No. CIV-PT-18–01-02705; Protocol No. EC.01.01.17) was previously approved by the Portuguese National Authority of Medicines and Health Products, I.P. (INFARMED), after being submitted in the National Registry of Clinical Studies (RNEC, No. 30122), by the National Ethics Commission for Clinical Research (CEIC, RNEC No. 30121) and National Commission for the Protection of Data (CNPD).