Ethical considerations
CNPD
DER
iBone Therapies (European Databank on Medical Devices, EUDAMED, No. CIV-PT-18–01-02,705; 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). The production of DEXGEL was carried out in a clean room with ISO class 4 classification, suitable for the production of medical devices, at the facilities of RESDEVMED Unipessoal Lda (Ovar, Portugal). Qualified candidates were provided all the necessary clarifications so that they could make an informed consciousness decision. Twelve participants provided written informed consent. All participants were covered by a civil liability insurance from Haftpflichtverband der Deutschen Industrie (HDI) company. This study followed CONSORT 2010 statement guidelines for reporting parallel group randomized trials.