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Some inter-individual variation and overlapping between study groups occurred.
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The greater effect on malaria incidence observed in the intervention group occurred mainly in the high endemicity stratum ("stratum 1"), while no difference between study groups was observed in the low endemicity stratum ("stratum 2"; Figure 2.2).
The limit between the two groups occurred between 14 and 19% TS in this study and is consistent with literature data, although this limit has not been clearly defined with values varying between 15 and 20% TS [ 3, 8, 9].
At 3 months of follow-up no switch of patients between groups occurred.
Future studies should estimate the prevalence of diarrhoea in the dry season, or for an entire year, to determine if these differences between groups occur year round.
The second model (with interaction) confirmed that there was an interaction between time and treatment (p = 0.03) and differences between the study groups in pain estimations occurred at the following time points: 120 minutes (MA pain scores lower than EA), 270 minutes (MA pain scores lower than EA), and 360 minutes (SC pain score lower than MA).
No statistically significant differences in demographic and medical characteristics occurred between the study groups (Table).
HR did not change within the groups nor did a difference occur between the study groups and controls (range, 84.3 (SD 36.3) to 138.3 (SD 15.7) min-1).
The remaining two exteriorizations without proven infection (one in the study group and one in the control group) occurred between the 1st and the 2nd year after implantation.
Two deaths (one per group) occurred during the study.
Detection bias occurs when there are systematic differences between the study groups in the assessment of the outcome [ 19].
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