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Please insert this code. HaBarzel street 38, Square Tower, Ramat Hachayal, Tel Aviv. Sample size calculation and determination, statistical analysis plan and statistical report. Pharmacokinetic parameters calculations based on C-max, T-max, AUC0-t, λz, T1/2. CRF design, EDC solutions, database design and development, double data entry and reconciliation. Clinical development plan, investigator brochures, regulatory submission and licensing maintenance documents. Write down statistical analysis plan.