Sample size considerations

CO Catherine E. Oldenburg
AA Ahmed M. Arzika
RM Ramatou Maliki
MK Mohamed Salissou Kane
EL Elodie Lebas
KR Kathryn J. Ray
CC Catherine Cook
SC Sun Y. Cotter
ZZ Zhaoxia Zhou
SW Sheila K. West
RB Robin Bailey
TP Travis C. Porco
JK Jeremy D. Keenan
TL Thomas M. Lietman
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The sample size for the morbidity communities was based off the primary morbidity outcome, which was macrolide resistance in Streptococcus pneumoniae. We assumed 12% baseline resistance (based on previous studies) and an ICC of approximately 0.051 (based on the Trachoma Elimination Follow-up study [15]). We estimated that inclusion of 30 villages (15 per arm) and 10 samples per community would yield approximately 80% power to detect a difference in prevalence of resistance of 18% (e.g., 12% versus 30%) assuming 80% carriage of S. pneumoniae. For the infant adverse event survey, the sample size was limited by the number of 1 to 5 month old children residing in the 30 communities during the study period.

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