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Developing, Planning and Conducting an Interim Analysis: Lessons from the DEVOTE Cardiovascular Outcomes Trial (trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events).

Theilgaard Hanne,Mollerup Inger, Helmark Ida Carøe,Endahl Lars, Hoskin Shawn, Hvelplund Anders,Amby Lene Klixbüll,Moses Alan C.

Therapeutic Innovation & Regulatory Science(2019)

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Key words
Interim analysis,cardiovascular outcomes trials,data access management plan,insulin degludec,insulin glargine U100
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