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Assessed for eligibility (N = )

Assessed for eligibility (N = ). Excluded (n = ) Not meeting inclusion criteria (n = ) Refused to participate (n = ) Other reasons (n = ). Patients randomly assigned (n = ). Allocated to intervention (n = ) Received allocated intervention (n = )

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Assessed for eligibility (N = )

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  1. Assessed for eligibility (N = ) Excluded (n = ) Not meeting inclusion criteria (n = ) Refused to participate (n = ) Other reasons (n = ) Patients randomly assigned (n = ) Allocated to intervention (n = ) Received allocated intervention (n = ) Did not receive allocated intervention (n = ) Allocated to intervention (n = ) Received allocated intervention (n = ) Did not receive allocated intervention (n = ) Lost to follow-up (n = ) Discontinued intervention (n = ) Lost to follow-up (n = ) Discontinued intervention (n = ) Analyzed (n = ) Excluded from analysis (n = ) Analyzed (n = ) Excluded from analysis (n = )

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