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This approach was further tested in filings for a subsequent phase 3 study where the tablets used a different film-coat.
These discussions were held in 2009 as part of a review process that fed into the proposal for a subsequent phase of RENEWAL.
The RD for a subsequent phase II clinical trial was estimated to be 65 mg/m CDDP and 80 mg/m S-1.
Based on these findings, the eltrombopag dose of 100 mg once daily (−5/+5 dosing schedule) was chosen for a subsequent phase II study of eltrombopag versus placebo in thrombocytopenic patients receiving gemcitabine-based chemotherapy, which is ongoing.
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This study will lay the foundation for the design of a subsequent Phase II or Phase III RCT by (a) providing effect sizes that can be included in a power analysis for sample size estimation and (b) investigating whether aerobic capacity, muscle strength, and balance are possible factors associated with the beneficial effect of exercise training on walking outcomes.
The main goal of phase I cancer clinical trials is to determine the highest dose of a new therapy associated with an acceptable level of toxicity for the use in a subsequent phase II trial.
Recognizing that completing a 70-item instrument was time-consuming and tedious for both students and preceptors, a subsequent phase of analysis tested whether a more streamlined instrument could be devised, and one which maximized the scales' differential abilities to discriminate between enhanced APPE and their traditional counterparts.
But he said permits were being processed for an additional two million square feet of office space and for 5,000 apartment units in a subsequent phases.
Under this approach, the qualitative stage focused on developing relevant categories and themes as the basis for a subsequent quantitative phase, which focused on evaluating the possibilities of generalizing the qualitative results (Creswell and Clark, 2011; Teddlie and Tashakkori, 2009).
Phase I studies are classically set up to detect acute treatment-related toxicities with a view to detecting dose-limiting toxicities and to recommend a dose for subsequent phase II testing (LoRusso et al, 2010 ).
These preclinical studies provided a rationale for subsequent phase II/III clinical trials combining lapatinib with various antiestrogen therapies.
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