A) Sequence generation
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1. Was the method of randomization adequate?
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Yes / No / Unsure
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B) Allocation concealment
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2. Was the treatment allocation concealed?
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Yes / No / Unsure
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C) Was knowledge of the allocated interventions adequately prevented during the study?
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3. Was the patient blinded to the intervention?
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Yes / No / Unsure
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4. Was the care provider blinded to the intervention?
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Yes / No / Unsure
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5. Was the outcome assessor blinded to the intervention?
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Yes / No / Unsure
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D) Incomplete outcome data
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6. Were incomplete outcome data adequately addressed?
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E) Other sources of potential bias
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7. Were all randomized participants analyzed in the group to which they were allocated?
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Yes / No / Unsure
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8. Were the groups similar at baseline regarding the most important prognostic indicators?
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Yes / No / Unsure
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9. Were co-interventions avoided or similar?
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Yes / No / Unsure
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10. Was the compliance acceptable in all groups?
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Yes / No / Unsure
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11. Was the timing of the outcome assessment similar in all groups?
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Yes / No / Unsure
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