Conducting:   Report:  
Question Assessment Question Assessment
Are definitions of reported adverse effects given? Yes, however, there is a description overlapping about procedure and antibiotic prophylaxis adverse effects. Were adverse effects reported adequately? It is not clear. They just described adverse effects that never happened and only one that happened in the intervention group.
Were the methods used for monitoring adverse effects reported? Use of prospective or routine monitoring; spontaneous reporting; patient checklist, questionnaire or diary; systematic survey of A checklist was used to recollect data (we asked the author). Were any patients excluded from the adverse effects analysis? No, there were 6 lost to follow up patients in placebo group and 3 patients in intervention group. They did not report any adverse effect.
• Were the methods to detect AE rigorous? No, they just described variables and the checklist they used. No other data to support this item. Does the report provide numerical data by intervention group? Yes, one patient had nausea (n=138)
    Which categories of adverse effects were reported by the investigators? They were not described. They just described the variables.
    Did the researchers report all important or serious adverse effects? How were these AE defined? Yes, they were reported but definitions were by event not by category. The events were: emesis, diarrhea, delirium, hallucinations, headache, seizures and rash.
    Were reported the adverse effects considered for monitoring? Yes, all of them were reported.
Table 2: Risk of Bias for Adverse effects García-Perdomo, [9].