1.       The file template named “How to write the consent form?” can be used as a guide to improve the writing of the informed consent. This template can be downloaded from the templates on the MREC website (Account - MREC). This is because the attached informed consent is not focused on the study. It contains many unnecessary and/or irrelevant statements. The speech in the informed consent should be directed to the parents of participating children. The participating older children are requested to provide assent, especially for withdrawal of blood sample.

2.       The scientific committee: No. However, this committee was specified in form # 90 .

3.       The background: What about the prevalence of the disease in Egypt and other countries, management lines, …

4.       According to the written methods it is a cross-sectional study. The term “cohort” is used for longitudinal studies.

5.       What are the criteria for provisional diagnosis of Pyle’s disease?

6.       What about male and female groups and numbers, smoking of parents, and other inclusion and exclusion criteria

7.       The sample size was mentioned as a range from 5-10. Please specify the sample size. Also, cite a reference for this sample size and clarify the importance of a pilot study in calculating sample size in the study.