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This was an open, noncomparative, two centre, phase II trial.
Two hundred mother infant pairs were enrolled in a single centre, phase II, double-blind, RCT.
The important limitation of our study is its single centre phase II design.
This is a single centre phase II trial conducted from February 2004 February 200505.
This was a two centre, phase I, dose-escalation, sequential cohort study.
This single centre phase I study used a modified Fibonacci design with a planned minimum of three patients at each dose level.
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Patients 1, 3, 4 and 5 were treated on a phase Ib/II multicentre study of ibrutinib (NCT01105247), while Patient 2 was enrolled on a single-centre phase II clinical trial of ibrutinib and rituximab (NCT01520519).
Here, we determined the safety and tolerability of low-level FK506 therapy in stable PAH patients.We performed a randomised, double-blind, placebo-controlled, 16-week, single-centre, phase IIa trial in PAH patients with New York Heart Association functional class II/III symptoms using three FK506 target levels (<2, 2-3 and 3-5 ng·mL-1).
A randomised, double-blind, placebo-controlled multi-centre phase III trial of XELIRI/FOLFIRI plus simvastatin for patients with metastatic colorectal cancer.
Large scale multi-centre phase III clinical trials often face challenges in terms of adequate and appropriate clinical study facilities, equipment and staff.
Also in a multi-centre phase IIa clinical trial FX06 significantly reduced the size of the necrotic core of infarcts in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention [22].
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