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This indication is based on the result of two large-scale, placebo-controlled, multicenter trials (PREEMPT: Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy) that demonstrated the efficacy, safety and tolerability of OnabotulinumtoxinA (155 195 U) as a prophylactic treatment for CM in adults [13 15].
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Regulatory approval for this indication was based on the phase III randomized trial, GOG 240, which demonstrated a statistically significant and clinically meaningful improvement in overall survival when bevacizumab was added to chemotherapy: 17.0 vs 13.3 months; HR 0.71; 98% CI, 0.54 0.95; p = .004.004
A second indication was based on the observation that the formation of signaling VEGFR2 complexes was biphasic in the direction of total VEGFR density, allowing the most efficient net "pro-angiogenic potential" to be reached within the order of 10,000 total VEGFR/EC (Fig. 5D).
For missing data, treatment indication was based on the 2 questions about physical activity from the invitation letter.
This indication is based on (summarize the limitations of available data that supported the approval)." This proposed labeling concept implies a willingness to consider data from multiple body sites and to use the labeling information as way to describe the limitations of the data to the prescriber.
The indication is based on strict criteria.
Many donor management protocols usually include steroids, but this indication is based on poor quality evidence and is subject to considerable debate in the literature [ 4– 9].
Any surgical indication is based on a favourable risk benefit balance.
This indication is based on theoretical considerations of Rudolf Steiner.
The assessment of indications was based on the patients' medical records.
The indications were based on the application of restricted criteria from the recently published position paper of the European Heart Rhythm Association (EHRA) and the guidelines on syncope of the European society of Cardiology (ESC).
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CEO of Professional Science Editing for Scientists @ prosciediting.com