Cho 2017.
Methods |
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Participants |
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Interventions | Treatment group
Placebo group
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Outcomes | Primary outcome measures
Secondary outcome measures
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Funding sources | None. | |
Declarations of interest | None. | |
Notes | Participants were followed up at days 14 (visit 1), 28 (visit 2), 60 (visit 3), and 90 (visit 4) after initiation of medication. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was carried out by the Medical Research Collaboration Center of Seoul National University Bundang Hospital using random permuted blocks of different sizes. The size of the next block was randomly chosen from the available block sizes." Comment: This method of random sequence generation was considered to have low risk of bias. |
Allocation concealment (selection bias) | Low risk | Quote: "The size of the next block was randomly chosen from the available block sizes. Randomization was stratified by each recruiting study site." Comment: This method of allocation concealment was considered to have low risk of bias. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "One person packed the 14‐day supply of tablets for each patient. All study staff at all hospitals were blinded to treatment allocation and remained blind until the end of the trial." Comment: double‐blind; therefore low risk of bias. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No quotes available. No blinding of outcome assessments described. Comment: Owing to insufficient information, risk of detection bias was considered to be unclear. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No quotes available. Figure 1 shows a detailed flow diagram of participant follow‐up, including information regarding loss to follow‐up, exclusion due to adverse events, or need for intervention. Comment: Detailed information on participant follow‐up was available; risk of attrition bias was considered to be low. |
Selective reporting (reporting bias) | Low risk | No quotes available. Expected outcomes were reported according to objectives. Comment: Information on primary and secondary outcomes was presented in detail in the protocol at www.clinicaltrials.gov. Risk of reporting bias was therefore considered to be low. |
Other bias | Low risk | No quotes available. Study appears to be free of other sources of bias. Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low. |