Study Design In this randomized, open-label trial, all of the individuals received a fixed-dose mixture tablet containing 90 mg of ledipasvir and 400 mg of sofosbuvir, administered orally once daily. Randomization was stratified regarding to genotype , presence or lack of cirrhosis, and response to prior therapy . Start to see the Supplementary Appendix, offered by NEJM.org, for definitions of all types of response to prior therapy. Research Oversight This study was approved by the institutional review board or independent ethics committee at each participating site and was conducted in compliance with the principles of the Declaration of Helsinki, Good Clinical Practice guidelines, and local regulatory requirements. The analysis was designed and carried out according to the protocol by the sponsor in collaboration with the educational investigators.In those children, especially in males, it can cause serious intellectual disability and autism-like symptoms as the FMR1 gene shuts down and non-e of the normal protein is produced. In fact, says Todd, it's often only after a child is identified as having Fragile X syndrome through genetic testing that their grandfather or grandmother realizes that their own symptoms stem from FXTAS. Doctors in U-M's Neurogenetics clinic for adults, and the Pediatric Genetics Clinic at U-M's C.S. Mott Children's Hospital, work together to address the requirements of Fragile X households routinely.