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GTH OF STUDY: How long will each patient participate; what is anticipated duration of study.
STUDY SCHEDULE: Provide timetable indicating when the study procedures and evaluation are to be performed on each patient.
SPONSOR: Source of funding.
SUMMARY OF PROJECT (in laymen's terminology): Brief description of project objectives, rationale, methods.
VARIABLES FOR ANALYSIS: List those to be used, i.e., efficacy, safety.
METHOD OF STATISTICAL ANALYSIS