Statistical analysis plan for the LAKANA trial: a cluster-randomized, placebo-controlled, double-blinded, parallel group, three-arm clinical trial testing the effects of mass drug administration of azithromycin on mortality and other outcomes among 1–11-month-old infants in Mali

Statistical analysis plan for the LAKANA trial: a cluster-randomized, placebo-controlled, double-blinded, parallel group, three-arm clinical trial testing the effects of mass drug administration of azithromycin on mortality and other outcomes among 1–11-month-old infants in Mali

Abstract Background The Large-scale Assessment of the Key health-promoting Activities of two New mass drug administration regimens with Azithromycin (LAKANA) trial in Mali aims to evaluate the efficacy and safety of azithromycin (AZI) mass drug administration (MDA) to 1–11-month-old infants as well...

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Bibliographic Details
Main Authors: Juho Luoma, Laura Adubra, Dagmar Alber, Per Ashorn, Ulla Ashorn, Elaine Cloutman-Green, Fatoumata Diallo, Camilla Ducker, Riku Elovainio, Yue-Mei Fan, Lily Gates, Gwydion Gruffudd, Tiia Haapaniemi, Fadima Haidara, Lotta Hallamaa, Rikhard Ihamuotila, Nigel Klein, Owen Martell, Samba Sow, Taru Vehmasto, Yin Bun Cheung
Format: Article
Language:English
Published: BMC 2023-11-01
Series:Trials
Subjects:
Cluster randomized trial
Statistical analysis plan
Antibiotic
Azithromycin
Mortality
Morbidity
Online Access:https://doi.org/10.1186/s13063-023-07771-6

Internet

https://doi.org/10.1186/s13063-023-07771-6

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