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This trial will include patients with POEMS syndrome who represent close to 10% of the entire Japanese patient population; thus, the results are generalisable.
Safety-relevant data to determine the primary endpoint of this trial will include reporting of any adverse event, laboratory and other safety parameters determined in the trial visits.
This trial will include patients with vascular-related end-organ damage (such as moderate renal dysfunction or microalbuminuria) as well as patients with prevalent cardiovascular risk factors, such as hypercholesterolemia or hypertension, and will allow for long-term safety assessments.
This trial will include a follow-up of 1 month, to evaluate the short term outcomes of self-management practice and self-efficacy, as well as condition knowledge and health-related quality of life.
· Participants eligible for this trial will include male and non-child-bearing potential female patients age 21 years and older who have (a) documented coronary artery disease > 30 day; and (b) evidence of suboptimal type II diabetes control on the basis of Hb A1c ≥7.0%, despite the use of oral antidiabetic monotherapy.
This trial will include consecutive adult patients with an acute (up to 15 days) displaced, unstable fracture of the distal end of the radius of type A2, A3, C1, C2 or C3 by the Arbeitsgemeinschaft für Osteosynthesefragen Association for the Study of Internal Fixation classification and type II or type III by the IDEAL classification, without previous surgical treatments of the wrist.
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Asparouhov says the trial will include two classrooms, with a teacher at the front of each class and students and therapists working together.
The main resource uses monitored during the trial will include the following: 1. Diagnostic testing procedures implemented.
Additional data to be collected during the trial will include staffing, resource use and costs for the intervention, and the distance travelled by patients and their families.
Primary analysis of the trial will include any child permanently residing with an eligible woman at the time of the baseline survey, regardless of whether the child is the offspring of the eligible woman or not.
Secondary outcome measures in this exploratory trial will include change (from randomisation to 3 and 6 months) in visual disability as measured using the 7 item NEI VFQ and the near vision subscale of the VFQ-48 and, change in 'generic health related quality of life' as measured using the EQ-5D [ 18, 19].
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