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All relevant clinical information was collected on paper and later entered electronically using REDCap software [21], a web-based electronic database, compliant with good clinical practice, as defined by the International Conference on Harmonization [22]. The identity and information of trial participants was kept confidential and secured in a locked cabinet at the trial site.
Copyright and License information: ©2020 Mandro et al
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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