1-      Typo in Arabic title

2-      The principal investigator has only a Bachelor degree in Medicine, and her role in the research is not mentioned.

a.      Please indicate her role

b.      Who will do the procedure in this high-risk research.

3-      What is the amount of funding?

4-      The background is too deficient

a.      Explain both procedures with risks and benefits

b.      Mention the scientific gap

c.       Mention what will this study add, and how it will fill the scientific gap

5-      Details of sample size calculation are missing, e.g. What is the power, error, etc.

6-      How will the participants be randomized?

7-      Is there masking/blinding or not?

8-      According to the Egyptian law, it is better to enroll participants 21 years and above

9-      What is the follow up schedule?

10-  Benefits

a.      as mentioned, benefits are for which of the groups? The consent mentions that there are no direct benefits to the participants.

b.      If participants do not enroll in the study, won’t they have any type surgery outside the research?

11-  What are the informed consent procedures, e.g. who will take consent, where?

12-  Informed Consent form

a.      The grouping and randomization must be mentioned

b.      The consent mentions repeated testing, how many times and how much blood will be collected each time?

c.       What alternative treatment or surgery will the patients get if they refuse to participate?