Comments:

Study Design: The application form states this is an observational study. However, the details provided suggest it is a Clinical trial. Please clarify the study design methodology.

Exclusion Criteria: The exclusion criteria require clarification. Please ensure they are clearly defined and relevant to the research question.

Ethical Review: The research appears to fall under Article 4 of the relevant law. Therefore, approval from the Egyptian Drug Authority and the Supreme Council for Ethical Review is necessary.

Informed Consent: The provided informed consent form may require revisions. Some phrases seem unclear, inapplicable to research, or contain unnecessary information. Please review and revise the consent form to ensure it provides clear and accurate information to participants.