|
1. Study Question & Population
|
Defined
|
12. Patient, Care Giver & Assessor
|
Blinded
|
|
2. Treatment & Placebo
|
Described
|
13. Informed Consent
|
Obtained
|
|
3. Inclusion Criteria
|
Specified
|
14. Statistical Method
|
Specified
|
|
4. Exclusion Criteria
|
Specified
|
15. Statistician Author*
|
No
|
|
5. Main Outcome Measures
|
Listed, Many
|
16. Intent to Treat Analysis
|
Performed
|
|
6. Multipractice Study
|
Yes
|
17. Baseline Characteristics
|
Reported
|
|
7. Sample Size & Power
|
Calculated
|
18. Groups Similar at Baseline
|
Mostly
|
|
8. Missing Data & Losses
|
Allowed For
|
19. Dropouts Reported
|
Yes
|
|
9. Randomization Method
|
Described
|
20. Dropout Rate
|
Below 10%
|
|
10. Central Randomization
|
Yes
|
21. Reasons for Dropouts
|
Given
|
|
11. Randomization Concealment
|
Adequate
|
22. Findings Support Conclusion 3
|
Apparently
|
