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. 2019 Jan 18;2019(1):CD011825. doi: 10.1002/14651858.CD011825.pub2

Andremont 1981.

Methods Design: randomised, placebo‐controlled, parallel‐group trial
Participants Number assigned: 48 adults (macrolide n = 24, placebo n = 24)
Age in years: N/A
Setting: healthy US residents travelling to Mexico to attend a professional meeting
Interventions Indication: prevention of traveller's diarrhoea
Type of macrolide: erythromycin base
Route: per oral
Dose per day: 1000 mg
Duration of treatment: mean days of treatment 6 (range 4 to 13 days)
Total treatment dose: 6000 mg (mean)
Outcomes Adverse events stated as an outcome in trial registration/protocol/paper: no
Adverse events ascertainment: unclear
Adverse events: states that no adverse events were reported
Antimicrobial resistance: not reported
Death: not reported
Funding sources Study supported by a "contrat de recherche clinique" from Institut Gustave Roussy and a grant from Roussel‐Uclaf Laboratories.
Notes Concomitant medication: unclear
Note: gastrointestinal symptoms were reported as the primary outcome in this study and not reported/regarded as an adverse event.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation
Allocation concealment (selection bias) Unclear risk Allocation not described.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Identical‐appearing placebo
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Blinding of participants and clinicians
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No dropout
Selective reporting (reporting bias) Unclear risk Adverse events not stated as an outcome and unclear ascertainment. However, states that no adverse events were reported.
Other bias Low risk None were identified.