What is the purpose of this trial?
To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment, confirmed by a second sample collected 7 days after the first sample.
Fresenius Kabi DEutschland GmbH
Dates: 07/07/2017 - 10/31/2017
Last Updated: 07/19/2017
Study HIC#: 1510016597