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Preclinical studies have been flawed by use of models of transient not permanent brain ischaemia, treatments that aim to protect cerebral grey matter independently of white matter, delivery of the study drug within too short a time window after ischaemic insult, use of surrogate outcome measures in the short term instead of function in the long-term, and small sample sizes.
CSG, AJH, CF, AB, AJ, RT, LB contributed to the design and delivery of the study.
HD is Study Manager and coordinated the operational delivery of the study protocol across the UK.
All sites are based in Montreal to ensure ease of oversight in the delivery of the study.
CH, BW, LH and MZM are responsible for clinical delivery of the study and provided details of the operalisation of the trial.
JN conceived of the study, and participated in its design, was responsible for coordination and delivery of the study, interpretation of results and revising the manuscript.
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These challenges were reflected in design and delivery of the studies and interventions.
Women and their health care providers therefore do not need to do anything at the time of delivery for the study.
A theory-driven process evaluation confirmed that there were no differences in visits, deliveries of the study foods, message recall, or rates of consumption of study foods between the treatment groups [ 25].
Survey findings have informed the content and delivery of the PEARL study national clinical quality improvement study, results from which will be published separately.
The biostatistician will notify the study pharmacist of the assignment and he/she will arrange for delivery of the appropriate study medication (MMF or matched placebo) the center investigator responsible for management of the patient.
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