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Long-term treatment of chronic migraine with OnabotulinumtoxinA: efficacy, quality of life and tolerability in a real-life setting.
Efficacy studies in humans are currently ongoing, following successful studies in the mdx mouse [10], and safety and tolerability in a phase I trial [11].
The research question about safety and tolerability in a review may be broad or narrow in scope.
Therefore, when adding a new drug to a standard dose of chemotherapy, a dose-finding study would be needed to investigate the efficacy and tolerability in a phase II study, similar to our study.
All three AIs almost completely block estrogen synthesis and have been approved by the Food and Drug Administration for the treatment of early-stage breast cancer because of their efficacy and tolerability in a variety of clinical settings [ 36].
Although these studies are not structured randomized controlled trials, they do provide valuable data regarding drug efficacy and tolerability in a patient population that is more reflective of community practice.
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Schey et al., who examined its safety and tolerability in relapsed refractory MM patients in a phase I clinical trial, initially carried out a formal study of pomalidomide.
In a phase 2 clinical trial (n = 111), S-1 monotherapy showed activity and tolerability in metastatic breast cancer with a response rate of 42%, warranting further research on the role of S-1 in breast cancer [ 8].
In addition, the efficacy of VSL#3 in the induction and maintenance of remission and their safety and tolerability in children has been evaluated in a prospective, 1-year (or until relapse), placebo-controlled, double-blind study conducted by Miele et al. [ 23].
Blinded safety and tolerability in each cohort were evaluated by an independent Data and Safety Monitoring Board in a blinded manner prior to initiation of enrollment of the next dosage cohort.
A phase I study of DV-1179 was conducted to assess its safety and tolerability in healthy volunteers followed by a phase Ib/IIa study of the safety and pharmacodynamics in patients with active SLE.
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