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最高研发阶段批准上市 |
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首次获批日期1985-12-24 |
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最高研发阶段批准上市 |
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首次获批日期1961-08-11 |
Double-blind, Placebo-controlled, Randomized Clinical Trial Comparing the Efficacy and Safety of Sialanar Plus orAl rehabiLitation Against Placebo Plus Oral Rehabilitation for chIldren and Adolescents With seVere Sialorrhoea and Neurodisabilties,
Double blind, placebo-controlled, randomised trial, multicentre in France with open-label tolerability phase.
The double-blind placebo-controlled study duration will be scheduled for 3 months with the final visit of the double-blind period at D84. After the D84 assessment, patients will be invited to continue into a 6-month openlabel study extension (OLSE) with ex-Sialanar® patients continuing the treatment and ex-placebo patients starting Sialanar®
Double-blind, placebo-controlled, randomized clinical trial comparing the efficacy and safety of Sialanar plus oral rehabilitation against placebo plus oral rehabilitation for children and adolescents with severe sialorrhoea and neurodisabilties - SALIVA study
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