Table 3 Basic outline that can be used to build a clinical study

1. Study Personnel

2. Background

3. Objectives

4. Study Design

 a. Study Type

 b. Study Overview

 c. Treatment Groups

 d. Randomization Procedures

 e. Blinding Procedures

5. Intervention and Placebo Details

6. Population Studied

 a. Institutional Protocol Review

 b. Informed Owner Consent

 c. Animal Identification

 d. Inclusion Criteria

 e. Exclusion Criteria

 f. Removal and Rescue Criteria

7. Assessments

 a. Veterinary Outcome Measures

 b. Owner Outcome Measures

 c. Patient Biologic Measures

8. Adverse Events

9. Statistical Analysis

10. Data Collection, Security and Independent Review

11. Protocol Deviations and Changes