Ethical approval
ICH
This study was conducted in compliance with ethical principles with their origin in the Declaration of Helsinki, the International Council for Harmonization (ICH) consolidated Guideline E6 for Good Clinical Practice (GCP) (CPMP/ICH/135/95), and applicable regulatory requirements including the Japanese Ministry of Health, Labor and Welfare Ordinance No. 28 of 27 March, 1997 and/or The Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics No. 1 of 25 November, 2014; and other applicable local regulations.