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Results of the CGD trial have been positive enough that Orchard Therapeutics, on whose scientific advisory board Williams sits, plans to conduct a registration trial for the treatment.
This study is also performed as a registration trial for regulatory approval.
This study was carried out as an investigator-initiated registration trial for label extension of S-1 in the treatment of esophageal carcinoma in Japan.
BRIM-3 was the registration trial for vemurafenib and randomized treatment-naïve patients with BRAF-V600E mutant melanoma in a 1 1 ratio to vemurafenib or dacarbazine.
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The company reports that they will now embark on Phase 3 registration trials for the intravenous formulation and continue to advance their oral formulation of CR845.
Further, future registration trials for potentially cognitive enhancing compounds may not only assess efficacy with cognitive performance measures, but with assessments of real-world functional outcome and functional capacity.
The teriparatide registration trial, like other registration trials for osteoporosis, did not randomize subjects with known stage 4 5 CKD.
Due to the limited literature, data on psychiatric adverse effects was also obtained from registration trials for boceprevir and telaprevir.
25 Of course, bevacizumab did not undergo registration trials for intravitreal use, but we can evaluate its safety based upon the comparative trials, CATT, IVAN, MANTA and GEFAL.
The registration trials for alendronate, risedronate, and ibandronate were conducted with daily dosing of medication, although the dosing interval most often used now is weekly for alendronate, weekly or monthly for risedronate, and monthly for oral ibandronate.
The exclusion criteria for registration trials for TPR or BOC [ 3- 7] were met by 65 patients (64%, e.g. history of hepatocellular carcinoma, history of stem cell transplantation, renal dialysis, Crohn's disease, thalassaemia major, autoimmune hepatitis and primary biliary cirrhosis).
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