1)         Experimental design:

1. Rationale for the selected models and endpoints
2. Adequacy of the controls
3. Route & timing of intervention including delivery method and dosing
4. Justification of sample size, including power calculation
5. Statistical methods used in analysis and interpretation of results

2)         Minimizing bias:

1. Methods of blinding (allocation concealment and blinded assessment of outcome)
2. Strategies for randomization and/or stratification

3)         Results:

1. Reporting of data from attrition or exclusion, negative, neutral and positive
2. Independent validation/replication, if funding is available
3. Validation/replication in a second species, if funding is available
4. Dose-response and therapeutic window analysis

4)         Interpretation of results:

1. Alternative interpretations of the experimental data
2. Discussion of effect size in relation to potential clinical impact
3. Potential conflicts of interest