
2.2. Study ethics
MINOR
This study will be conducted in accordance with the protocol and consensus ethical principles derived from the Declaration of Helsinki, the Council for International Organizations of Medical Sciences international ethical guidelines, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines, and Good Clinical Practice guidelines. The protocol, protocol amendments, and other relevant documents will be submitted to the institutional review boards of the participating sites for approval. All patients will be required to provide written informed consent/assent to participate in the study before undergoing any evaluations or procedures. For minor patients, written informed consent will be obtained from a parent/legal guardian. All patients will be informed about the use of their personal, study-related data in accordance with data protection laws. The information and results of this study will be disclosed at the clinical study registration site and other sites. The results of this study may be published or presented at scientific meetings.