Introduction

2.1 Primary Objective (or Aim) 1. 2.2 Secondary Objectives (or Aim) 1. 3. Investigational plan 2. 3.1 General Schema of Study Design 2. 3.2 Study Duration, Enrollment and Number of Sites 2. 3.2.1 Date Range of Study 2. 3.2.2 Total Number of Study Sites/Total Number of Subjects Projected 2. 3.3 Study Population 2. 3.3.1 Inclusion Criteria ... ................
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