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SinglePage PageMode: UseNone Language: en-US Outlines: Item: Title: New chemotherapy regimens and biomarkers for Chagas disease: the rationale and design of the TESEO study, an open-­label, randomised, prospective, phase-­2 clinical trial in the Plurinational State of Bolivia Children: Item: Title: Abstract Item: Title: Introduction Item: Title: Methods and analysis Children: Item: Title: Study design Item: Title: Objectives Children: Item: Title: Primary objectives Item: Title: BMKs for early assessment of therapeutic outcomes Item: Title: Rationale for the selection of host-derived and parasite-derived BMKs Children: Item: Title: Host-derived BMKs Children: Item: Title: Lytic anti-α-Gal antibodies to tGPI-mucins and α-Gal-NGPs Item: Title: Antibodies to T. cruzi-derived recombinant proteins KMP11, Hsp70, and PFR2, and peptide 3973 Item: Title: Parasite-derived BMKs Children: Item: Title: Detection of TESA by aptamers Item: Title: Secondary objectives Item: Title: Endpoints (outcome measures) Children: Item: Title: Efficacy endpoints Item: Title: Safety endpoints Item: Title: popPK endpoints Item: Title: Parasite genotyping Item: Title: Patient eligibility and exclusion criteria Item: Title: Recruitment, randomisation, treatment and follow-up of patients Item: Title: Study organisation Item: Title: Laboratory procedures Item: Title: Conventional serology Item: Title: Safety laboratory parameters Item: Title: qPCR assays Item: Title: BZN and NFX serum concentrations Item: Title: Safety management Item: Title: Data and safety monitoring board Item: Title: Sample size Item: Title: Data management and statistical analyses Item: Title: Resources and data availability Item: Title: Ethics statement, patient confidentiality, and dissemination policy Item: Title: Patient and public involvement Item: Title: Standard Protocol Items: Recommendations for Interventional Trials Reporting guidelines Item: Title: Discussion Children: Item: Title: Trial status and its adaptation to 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