 Data management: All data will be entered electronically. Patient files are to be stored in Numerical order in a secured place. This will be carried out by ZElshamy Statistical methods Data analysis All Data will be collected, checked, revised, tabulated and entered into the computer by ZElshamy. Quantitative variables from the normal distribution will be expressed as mean and standard deviation SD values. To test the significant differences between two groups at different follow-up periods student t-test will be used. Significant level will be set at P 0.05 Statistical analysis will be done using Statistical Package for Social Sciences, Version 21.0 SPSS, IBM, Chicago, III, USA for Windows. Data monitoring: The main supervisor is responsible for data monitoring if harms arise, an interim analysis will be done. El Mahallawi O. 