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p = 0.01 in patients with eGFR 60 ml/min/1.73 m 2 the changes of thoracic fluid index after liraglutide and placebo were similar (0.2 [95%CI ( 8.9)(9.2)] and 1.1 [95%CI ( 0.9)(3.0)], respectively) ( p = 0.50)
Diabetologia (2017) 60(8):13909
For 505(b)(2) applicants developing a fixed-dose combination, the FDA requires proof that each active ingredient contributes to the overall effect
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