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With regard to the substantial clinical improvement criterion, the applicant asserted that REBYOTA TM represents a substantial clinical improvement over existing technologies because it offers a treatment option for a patient population unresponsive to, or ineligible for, currently available treatments, and because the use of REBYOTA TM significantly improves clinical outcomes relative to the treatment options previously available
1 It is associated with monosodium urate crystals accumulating in joint fluid, cartilage, bones, tendons and other tissues
2016;146(2):427S-432S
Lung Cancer Management with Silibinin: a Historical and Translational Perspective
1 2 These support biological plausibility but do not meet the standard of clinical proof
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