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. 2012 Nov 14;2012(11):CD002203. doi: 10.1002/14651858.CD002203.pub4

Saiman 2010.

Methods Multi‐centre placebo‐controlled parallel design.
Participants Young CF patients (6‐18 years) without chronic P. aeruginosa airway infection (clear (2 or more cultures) for > 12 months)
Interventions Azithromycin (250 mg 3 times a week, increased to 500, if weight >36 kg) versus placebo; for 6 months.
Outcomes Primary: relative change in FEV1 from baseline.
Secondary: respiratory exacerbations; treatment requirements; and adverse events. Acquisition of resistant bacteria in respiratory culture. Authors contacted for full data on nutritional outcomes.
Notes Second North American study.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk University of South Florida generated assignments via secure centralized randomisation system.
Allocation concealment (selection bias) Low risk Data co‐ordinating centre distributed blinded study drug kits.
Blinding (performance bias and detection bias) 
 All outcomes Low risk Identically packaged tablets.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Modified ITT analysis (3 patients in placebo arm did not receive study drug and were removed) of primary outcome and most others.
Selective reporting (reporting bias) Low risk All outcomes reported.
Other bias Low risk Very clearly reported study.