Antimalarial artesunate-mefloquine versus praziquantel in African children with schistosomiasis: an open-label, randomized controlled trial.
Journal Information
Full Title: Nat Med
Abbreviation: Nat Med
Country: Unknown
Publisher: Unknown
Language: N/A
Publication Details
Subject Category: Molecular Biology
Available in Europe PMC: Yes
Available in PMC: Yes
PDF Available: No
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"these documents as well as the redcap codebook and statistical codes have been publicly available in the zenodo repository (at https://zenodo org/records/10089112 ; 10 5281/zenodo 10089112).; individual participant data have been deposited in zenodo also but is subject to controlled access due to privacy reasons and the european data protection legislation and can only be accessed after review and approval by the data access committee (dac) of the institute of tropical medicine (full information at https://www itg be/en/research/data-sharing-and-open-access ).; code availability in line with the previous statement statistical codes have been made available in the zenodo repository (see above for identifiers). data sharing agreement before data can be shared. code availability in line with the previous statement statistical codes have been made available in the zenodo"
"Competing interests The authors declare no competing interests."
"This study was supported by the Flemish Ministry of Economy, Sciences and Innovation (EWI), which was granted in the framework of the Structural Research Funding of ITM (SOFI), a competitive internal grant of the Institute of Tropical Medicine (grant number DIR/av/2018/90; obtained by E.B. and K.P.). The funder of the study had no role in study design, data collection, data analysis, data interpretation or writing of the report. We are grateful to the Cipla company for providing both study drugs at no cost. The company had no role in study design, data collection, data analysis, data interpretation or writing of the report. We also thank all nurses, community health workers, laboratory technicians, school teachers and directors and community leaders, without whom this trial would not have been possible. We want to especially highlight the tremendous efforts of the field staff, who maintained all follow-up samplings on schedule through door-to-door visits during the COVID-19 pandemic. We are also grateful to the members of the Data Safety Monitoring Board (DSMB) for their critical and regular review of the trial data. The DSMB was composed of (1) D. Van Der Linden, pediatrician specialized in Infectious Diseases, Catholic University of Louvain, Belgium, (2) F. Gobbi, Sacro Cuore don Calabria Hospital, Negrar, Italy, and (3) T. Pistone, University Hospital of Bordeaux, France, both internists specialized in Infectious and Tropical Diseases."
"Data availability: Open access information on the SchistoSAM trial such as the trial protocol, informed consent form and statistical analysis plan is published in the Clinicaltrials.gov registry with code NCT03893097. These documents, as well as the REDCap codebook and statistical codes have been publicly available in the Zenodo repository (at https://zenodo.org/records/10089112; 10.5281/zenodo.10089112). Individual participant data have been deposited in Zenodo also, but is subject to controlled access due to privacy reasons and the European data protection legislation and can only be accessed after review and approval by the Data Access Committee (DAC) of the Institute of Tropical Medicine (full information at https://www.itg.be/en/research/data-sharing-and-open-access). A request can be made by submitting a data access request form to ITMresearchdataaccess@itg.be/. The DAC will review the suitability of the data for the secondary research proposal, the amount of (indirect) identifiers needed and the possibility of sufficient anonymization, as well as the scientific value and ethical aspects, in collaboration with the principal investigators. An answer to the requests will be formulated within a month. The DAC has the expertise to anonymize the data (in line also with the European General Data Protection Regulation) and will draw up a data sharing agreement before data can be shared."
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Last Updated: Aug 05, 2025