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. 2017 Oct 30;2017(10):CD006491. doi: 10.1002/14651858.CD006491.pub4

Potasman 2002.

Methods Design: RCT
Study dates: unclear
Malaria transmission pattern and local antimalarial drug resistance: not applicable
Adverse event monitoring: "Two days after drug ingestion, a second EEG was performed, and a blood sample for mefloquine level was obtained...Travelers were given forms on which to record adverse effects that appeared within 48 hours after drug intake"
Participants Number enrolled: 90
Inclusion criteria: not explicitly mentioned, included travellers from the Bnia Zion medical centre, Haifa, Israel
Exclusion criteria: "Travelers younger than 18 years; with a history of epilepsy or depression, known allergy to mefloquine, cardiac conduction block; using beta‐blockers; or who were pregnant...Travelers with an abnormal baseline EEG (unifocal or repetitive bursts)"
Country of recruitment: Israel
Country of malaria exposure: not applicable
Duration of follow up: 48 hours
Type of participants: non‐travellers
Interventions 1. Mefloquine (1 x Mephaquine 250 mg tablet, Mepha, Aesch, Switzerland) one dose
2. Mefloquine (1 x Larium 250 mg tablet, Roche, Basel, Switzerland) one dose
3. Placebo
Outcomes 1. Adverse events; any
2. Adverse events; other (neuropsychiatric, abnormal EEG 48 hours after ingestion)
Notes Funding sources: "Partially funded by Mepha Ltd, Aesch, Switzerland"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Eligible travelers were randomly assigned to one of three groups" "Randomization and statistical tests were carried out using Statmate and InStat"
Allocation concealment (selection bias) Unclear risk Comment: not mentioned
Blinding of participants and personnel (performance bias) 
 Adverse effects/events Unclear risk "Participants were unaware of their group assignment until they completed their tests"
Comment: methods used to blind participants not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "EEG pairs (pre‐ and post‐mefloquine) were examined separately by two senior neurologists who were unaware of group allocation"
Incomplete outcome data (attrition bias); efficacy Unclear risk N/A
Incomplete outcome data (attrition bias); safety Unclear risk Comment: data were provided for all participants who were not excluded on the basis of abnormal baseline EEG
Selective reporting (reporting bias); efficacy Unclear risk N/A
Selective reporting (reporting bias); safety Unclear risk "Adverse effects, mainly gastrointestinal and neuropsychiatric were noted in 26 travellers"
Comment: specific nature of each adverse effect is not noted per group
Other bias High risk Partially funded by Mepha Ltd, Aesch, Switzerland.
Comment: the role of the study sponsor was not clear