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In addition, the study had the secondary objective of harmonizing the multicentric clinical platform on common SOPs and procedures in order to both prepare cohorts for trials and to optimize all the operations required for the therapeutic trial conduction.
MWB participates in trial conduction.
FR participates in trial conduction.
FFFR participates in trial conduction.
JW participates in trial conduction.
NR participates in trial conduction.
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Clinical research is regulated in Europe by the 2001/20/EC Directive, which should harmonize national laws and administrative provisions regarding clinical trials conduction [1].
Table 2 summarises the procedures during a trial's conduction with detailed description and exact time of assessment.
We repeated the primary analysis and investigated the influence of risk of bias, continent of conduction of the trial, and studies that compared triplet versus doublet without identical backbones, excluding those trials with a high risk of bias score, trials conducted in Asia, and trials of which the backbone was not identical.
The trial was conducted according to the Declaration of Helsinki and its conduction was monitored by a steering committee and an independent data monitoring committee.
To understand the structure and pitfalls of trial design and conduction has to be part of modern medical education.
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