Efficacy analyses: Responses to treatment at follow-up 6 weeks and 12 weeks after treatment according to treatment of cutaneous leishmaniasis patients in Suriname from 2010–2013.
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1 Proportion of individuals cured in 3-day regimen group minus proportion of individuals cured in 7-day regimen group.* The left side of the 90% confidence interval exceeds the non-inferior margin of 15%. It can therefore not be concluded that the 3-day regimen is non-inferior to the 7-day regimen.** The left side of the 90% confidence interval exceeds the non-inferior margin of 15%; furthermore the right-side of the 90% confidence interval and the right side of the 95% confidence interval (not presented) is below 0, indicating that the 3-day regimen is not only non-inferior but the proportion of parasitological cured in this group is also lower than in the 7-day regimen group.#7-day regimen: 20 of 28 patients not clinical cured at follow up-visit week 6 did not accept the additional 3 injections of 300 mg PI as required according to the protocol; 2 of 8 patients not clinical cured but receiving additional injections received less than 3 injections; 1 patient clinical cured according to dermatologists based on clinical pictures was not considered cured by the care provider and received additional 3 injections, 1 person was lost to follow up but did receive additional treatment; overall 4 of these 24 did not had outcome data at follow up week visit 12. In conclusion: 20 patients in the 7 day regimen were not included in the per protocol analyses because of failure with respect to the additional treatment. 3 day regimen: 12 of 22 patients not clinical cured at follow up-visit week 6 did not accept the additional 3 injections of 300 mg PI as required according to protocol; 3 of 10 patients not clinical cured but receiving additional regimen received less than 3 injections; overall 2 of these 15 did not had outcome data at follow up week visit 12. In conclusion: 13 patients in the 3 day regimen were not included in the per protocol analyses because of failure with respect to the additional treatment.Efficacy analyses: Responses to treatment at follow-up 6 weeks and 12 weeks after treatment according to treatment of cutaneous leishmaniasis patients in Suriname from 2010–2013.
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2015-12-03



