Kato 2013.

Methods	Design: cross‐sectional cohort study Study dates: June 2009 to June 2011 Malaria transmission pattern and local antimalarial drug resistance: various, not specified Adverse event monitoring: patient self‐reported questionnaire
Participants	Number enrolled: 1119 eligible travellers, 316 enrolled Inclusion criteria: "travelers who visited Hibiya Clinic, and requested antimalarial drugs for malaria chemoprophylaxis from June 2009 to June 2011" Exclusion criteria: none mentioned Factors influencing drug allocation: "The choice of anti‐malarial drug was supported by sufficient explanation about the advantages and disadvantages (efficacy, method, duration, side effect, cost and approval) of each drug" Country of recruitment: Japan Region of malaria exposure: various (n): East Africa 76, West Africa 63, South Africa 50, Southeast Asia 36, Central Africa 36, South Pacific 21, South America 16, India 8, North Africa 5, Central America 1 Duration of exposure to malaria: mean 20.0 ± 9.6 days in the atovaquone‐proguanil group and 59.0 ± 15.9 days in the mefloquine group Type of participants: travellers
Interventions	1. Mefloquine (1 x 250 mg tablet, Mephaquin; Mepha) weekly, starting 1 week prior to arrival, during the stay, and continuing for 4 weeks after leaving the endemic area 2. Atovaquone‐proguanil (1 tablet containing 250 mg atovaquone and 100 mg proguanil, Malarone; GlaxoSmithKline) daily, starting 2 days prior to arrival, during the stay, and for 1 week after leaving the endemic area
Outcomes	1. Adverse effects (any vertigo/dizziness, nausea, abdominal pain, diarrhoea, headache, insomnia, depression, any cardiovascular, any gastrointestinal, any psychoneurotic, allergic reaction) 2. Discontinuations of study drug due to adverse effects
Notes	Funding sources: not mentioned Communications with the study authors: the study authors provided us with disaggregated study data for the following outcomes: vertigo/dizziness, nausea, abdominal pain, diarrhoea, headache, insomnia, depression. Because we did not get receive the full disaggregated data set, we also retained this study in the analysis of groups of symptoms
Risk of bias
Bias	Authors' judgement	Support for judgement
Other bias	Unclear risk	1. Confounding: moderate PTravellers in the mefloquine group were significantly younger than travellers in the A/P group (p=0.01)" 2. Selection of participants into the study: serious "316 of 1119 travelers (28.2 %) were enrolled" 3. Measurement of interventions: low The prescription has been provided by travel clinic which also performed the study and discontinuations have been reported 4. Departures from intended interventions: moderate No information was available regarding switches between interventions of interest 5. Missing data: low One participant in the mefloquine group appears to be missing from the adverse events analysis. No reason was given 6. Measurement of outcomes: serious Comment: the outcome measure was subjective; participants and personnel were not blinded 7. Selection of the reported results: low Study authors provided us with disaggregated study data for individual outcomes 8. Other: serious "The authors wish to acknowledge that Makoto Ono and Tomoko Kawamura of GlaxoSmithKline are highly appreciated for conducting Data Management and Statistics Analysis of this study"