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Table 1 Schedule of assessments

From: Povidone-iodine ear wash and oral cotrimoxazole for chronic suppurative otitis media in Australian aboriginal children: study protocol for factorial design randomised controlled trial

Visit #

0

1

2

3

Event

aScreening

Day1

16weeks

12months

Informed consent

    

Check informed consent

    

Randomisationb

    

Ear exam

    

Check inclusion/exclusion criteria

    

Nose and ear swabs

    

Lifestyle questionnaire

    

Clinical note review

    

Check recent audiology

    

General health check

    

Record antibiotic/study medication use

    

SAE reportingc

    
  1. aScreening is an ear exam to assess ear status and can occur on Day 1
  2. b Randomisation may be conducted at the time of screening
  3. cSevere adverse events reporting will occur throughout the study