Examples of Screening Period in a sentence
Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period.
QTc >470 milliseconds (msec) on a 12-lead ECG obtained during the Screening period.
Note: The Screening stool sample may be taken anytime during the Screening period but should be collected prior to any bowel prep.
Note: Section 4.1 describes the procedures to be carried out during Screening period.
This study uses a randomized, multicenter, double-blind, placebo-controlled parallel-group study design in which QAW039 or placebo is added to incoming SoC asthma therapy (Figure 1).The study will include:• a Screening period of up to 2 weeks to assess eligibility.
The site will give instructions to the subjects with the collection procedures.The fecal calprotectin sample collected during the Screening period will be used as the baseline.
Eligibility will be determined during the Screening period, which may last for up to 28 days before the Cycle 1 Day 1 visit.
If joint owners are named, the Death Benefit will be paid out on the death of the first owner.
PUPs will have monthly visits for the first 3 months and blood sampling every 3-5 ED for inhibitor testingThereafter, subjects will be offered to continue treatment in an extension study until a total number of at least 100 ED per subject will be accumulated or until marketing authorisation of the drug, with additional visits every 6 months.Amended toThe main study consists of a Screening period followed by at least 50 ED per subject.
Subjects will be considered enrolled in the study after all assessments have been completed during the Screening period and just prior to Eloctate or Emicizumab administration.