BMC Pediatrics

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Open Access Research article

Compared to placebo, long-term antibiotics resolve otitis media with effusion (OME) and prevent acute otitis media with perforation (AOMwiP) in a high-risk population: A randomized controlled trial

Amanda J Leach1*, Peter S Morris1,2, John D Mathews3 and the Chronic Otitis Media Intervention Trial – One (COMIT1) group1

Author Affiliations

1 Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia

2 NT Clinical School, Darwin, Northern Territory, Australia

3 Melbourne University, Melbourne, Australia

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BMC Pediatrics 2008, 8:23 doi:10.1186/1471-2431-8-23

Published: 2 June 2008

Additional files

Additional file 1:

Randomisation details and characteristics of non-randomised and discontinued children. Further details of method of randomisation (e.g. allocation concealment and blinding), reasons for ineligibility to be randomised, and withdrawals.

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Additional file 2:

Table 1. Carriage at randomisation. Nasopharyngeal carriage on the day of randomisation.

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Additional file 3:

Tables 2a & 2b. Ear assessments and carriage during therapy. Table 2a provides number (%) of children with each worst ear status at least once during therapy, and number of examinations (%) with each worst ear status during therapy. Table 2b provides number of swabs (%) with each OM pathogen during therapy.

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Additional file 4:

Tables 3a & 3b. Incidence rate ratios. Discussion of how incidence rate ratio was applied to data from this high-risk population. Table 3a Incidence per child year and incidence rate ratio (IRR) of each worst ear status during therapy. Table 3b: Incidence per child year and incidence rate ratio (IRR) of nasopharyngeal carriage of each OM pathogen¥ during therapy.

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