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Any adverse event that occurs in a clinical trial subject, which is assessed by the study investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the study procedure will be reported.
The relief aspects of the drainage basin analysis have relationship with the study of three-dimensional features involving area, volume, and altitude of vertical dimension of landforms to analyze different geo-hydrological characteristics (Hajam et al. 2013).
To ensure validity of the perceptions revealed by the farmers, settled pastoralists and transhumant pastoralists, the survey was led by a local Malian NGO (called AMEDD) which has a good relationship with the study communities.
AE were also classified by the causality relationship with the study drug.
The investigator rated the relationship with the study product as "not related", "doubtful", "possible" or "probable".
bAEs for which a causal relationship with the study drug was considered possible or probable.
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A relationship with the studied drug is probable.
Work related factors such as physical workload, farming and demands experienced at work showed no significant relationship with the studied outcomes.
All of these patients had chemotherapy between 1 and 4 months before study enrolment and/or received concomitant chemotherapy during the protocol, leaving the relationship with the studied drug uncertain.
The relationships with the study drug were reported as unlikely by the investigators.
Two death were observed in this study; they occurred during the run-in period and so any causal relationships with the study drug was excluded.> -wrap-foot> : Incidence rate The incidence of ADRs are summarized in Table 9.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com