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In Joseph's paper [ 3] it should be noted that the intent of combining stillbirths plus neonatal deaths as a measure of pregnancy outcome for interventional trial is well-intended.
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This trial has been designed according to the CONsolidated Standards Of Reporting Trials CONSORTT) statement, 12 and is reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement 13 and with reference to the Template for Intervention Description and Replication (TIDieR) checklist.
See Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist (Research Checklist) (Additional file 2).
(MP4 112000 kb) Additional file 2: Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist.
Five questions were omitted because they are designed for interventional trials.
The protocol is reported using the appropriate Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) items.
The optimal design and patient selection for interventional trials in radiogenomics seem trivial at first sight.
It consists of 208 healthy and pathological voices collected during a clinical study performed following the guidelines of the medical SIFEL (Società Italiana di Foniatria e Logopedia) protocol and the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement.
Our results suggest that cognitive development as assessed by the Mullen and Leiter-R and adaptive behavior assessment by the Vineland parent interview are suitable functional outcomes for interventional trials in MPS IIIA or IIIB, and that CSF enzyme assay may be a useful biomarker to assess central nervous system transgene expression in gene transfer trials.
The presence of two or more of these autoantibodies to islet autoantigens (such as insulin and/or GAD65 or IA-2, or insulin or ICA) can be used as entry criterion for interventional trials [54], [55].
This trial protocol is written in compliance with the Standard Protocol Items: recommendations for Interventional Trials (SPIRIT) guidelines.
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