Abstract |
Item 1. Structured summary of trial design, methods, results, and conclusions |
Introduction |
Item 2a. Scientific background and explanation of rationale |
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Item 2b. Specific objectives and/or hypotheses |
Methods |
Item 3. The intervention for each group with sufficient detail to enable replication |
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Item 4. Completely defined measures of outcome, including how and when they were assessed |
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Item 5. Statistical methods used to compare groups for primary and secondary outcomes |
Results |
Item 6. For each primary and secondary outcome, results for each group, and the estimated size of the effect and its precision |
Discussion |
Item 7. Trial limitations, addressing sources of potential bias, imprecision and, if relevant, multiplicity of analyses |
Other information |
Item 8. Sources of funding and other support |
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Item 9. Where the full trial protocol can be accessed, if available |