Emami 2009 IRN.

Methods	Trial design: Cluster‐RCT. Unit of randomization: Urban sectors. Number of clusters: 12 (6 pairs) sectors (7636 inhabitants in 3000 households). Entomological data: monthly collection of phlebotomine sandflies from fixed indoors sites and from outdoors courtyards using 30 sticky traps and 20 (unspecified) light traps, assessed at one year. Clinical data collection: Follow‐up questionnaires and examinations were conducted every month between August 2004 and July 2005. All members of the participating households were examined. The presence or absence of CL ulcers was indicated on the forms. Length of follow‐up: 12 months. Analysis: Analysed at cluster level.
Participants	In each city, 6 urban sectors were selected based on the pre‐intervention epidemiological survey of disease in the area so that all sectors had a similar size and distribution of disease. Each sector in a pair was at least 2 km away from the other. Endemic disease: CL caused by L. tropica.
Interventions	Olyset® long‐lasting permethrin Insecticide‐treated nets (weigh of about 750 g and a surface area 14 m²). No ITNs.
Outcomes	Number of new cases of CL, assessed at one year. Estimates of the density of the vectors.
Notes	Country: Iran (cities of Sedeh and Shiraz). Trial dates: April 2004 to July 2005. Trial sponsor: This investigation received technical and financial support from the WHO Eastern Mediterranean Region (EMR), Division of Communicable Diseases (DCD) and the WHO Special Programme for Research and Training in Tropical Diseases (TDR): EMRO/DCD/TDR Small Grants Scheme for Operational Research in Tropical and Communicable Diseases. Sample size: Not calculated. Compliance assessment: Done. Health educational messages were disseminated to ensure participants' compliance with the proper use of ITNs and that they did not use other methods of preventing phlebotomine sandflies. To ensure correct use of ITNs, 59 training sessions for families in the intervention group were carried out in schools and mosques. Pre‐intervention: Inhabitants of areas which most active cases of CL were recorded by health centres, were examined and forms were completed for each household during house‐to‐house visits. The interviewers examined scars and ulcers, recording cases that occurred during the 9 months before the interview. Students in all elementary schools were examined and questioned in the 2 cities.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"For each of the 6 pairs we used computer‐generated random numbers to allocate 1 sector to receive Olyset ITNs (intervention group) and the other sector to receive no nets (control group).
Allocation concealment (selection bias)	Unclear risk	Not reported.
Blinding (performance bias and detection bias) participants	Unclear risk	Not reported.
Blinding (performance bias and detection bias) investigators	Unclear risk	Not reported.
Blinding (performance bias and detection bias) Assessors	Unclear risk	Not reported.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No information on loss of clusters. Loss to follow‐up of 11 participants (8/3818 in the intervention group and 3/3818 in the control group).
Selective reporting (reporting bias)	Low risk	All outcomes mentioned in the methods were reported in the results.
Baseline measurements	Unclear risk	No baseline information. Questionnaire done, but not provided.
Statistical adjustment for clustering	High risk	No statistical adjustment for clustering was made in the primary analysis of this cluster‐RCT.
Other bias	Unclear risk	Trial authors did not provide a conflict of interest declaration.