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Study completers were eligible for a 6-month, open-label extension study of lurasidone utilizing flexible daily doses of 20 120 mg; extension completers were then eligible for an additional 18 months of continuation treatment with flexible, once-daily doses of lurasidone in the range of 20 80 mg.
Additional sample collections not involved in the GWAS were used for an extension study of significant results (Table 1).
This is consistent with the data reported from the extension study of the phase I/II trial.
An extension study of long-term rivaroxaban treatment to prevent recurrent VTE, EINSTEIN EXT, was also conducted.
This Phase III open-label randomized extension study of adults aged 18 to 60 years evaluated the immunogenicity and safety of AS03A-adjuvanted H5N1 pandemic vaccine.
Detailed methodology for both the short-term study and the follow-up, long-term extension study of LDX has been previously reported [ 5, 20].
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The government appointed Electrowatt Engineering Services of Zürich to oversee construction and eventually became responsible for the extension studies of future expansion projects.
We excluded 'open-label' extension studies of phase 3 trials.
In long-term extension studies of monotherapy, patients in the placebo arm received blinded metformin 500 mg.
Extension studies of all three drugs have further suggested that long-term tolerability and efficacy are consistent with that observed in the clinical trials [ 13- 17].
In the Phase III and long-term clinical extension studies of febuxostat, there was a numerical increase in investigator-reported cardiovascular events with febuxostat when compared to allopurinol.
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