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Borja Robert 11 months ago
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@ -17,9 +17,6 @@
- Qualification at EMA for art. 58 - Qualification at EMA for art. 58
- Safety of IVM up to 600μg/kg alone and in coformulation with albendazole - Safety of IVM up to 600μg/kg alone and in coformulation with albendazole
- Demonstrated efficacy agrainst T. trichiura in a pivotal trial in Sub-Saharan Africa - Demonstrated efficacy agrainst T. trichiura in a pivotal trial in Sub-Saharan Africa
- ## FDC of ivm/alb has the lowest level of investment risk of all candidates for Combination for STH treatment (STH Drug Combinations Expert Meeting, BMGF, April 2016)
- Main results of previous STOP projects: ALIVE pivotal Trial
- Investigadores principales de cada uno de los partners
- Timeline y milestones (cuáles se han cumplido?) - Timeline y milestones (cuáles se han cumplido?)
- __Proposed safety and effectiveness study__ - __Proposed safety and effectiveness study__
- *Primary objective*: To evaluate and compare safety of a [[FDC]] against [[Albendazole]] alone via [[MDA]] in two study areas in Kenya and [[Ghana]]. - *Primary objective*: To evaluate and compare safety of a [[FDC]] against [[Albendazole]] alone via [[MDA]] in two study areas in Kenya and [[Ghana]].
@ -38,6 +35,9 @@
- *Countries*: [[Ghana]] and [[Kenya]] - *Countries*: [[Ghana]] and [[Kenya]]
- *Epidemiologic conditions of the sites*: Ongoing [[STH]] deworming activities - *Epidemiologic conditions of the sites*: Ongoing [[STH]] deworming activities
- -
- ## FDC of ivm/alb has the lowest level of investment risk of all candidates for Combination for STH treatment (STH Drug Combinations Expert Meeting, BMGF, April 2016)
- Main results of previous STOP projects: ALIVE pivotal Trial
- Investigadores principales de cada uno de los partners
- Ideas generales importantes - Ideas generales importantes
- Dosing strategies for Ivermectine are being revisited - Dosing strategies for Ivermectine are being revisited
- The fix-dose coformulation of Albendazole/Ivermectine is due to enter regulatory agencies - The fix-dose coformulation of Albendazole/Ivermectine is due to enter regulatory agencies

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