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The trial was undertaken according to the International Conference on Harmonization, Good Clinical Practice guidelines and was monitored by GSK Biologicals.
The trial was undertaken according to the International Conference on Harmonization, Good Clinical Practice guidelines and was monitored by GlaxoSmithKline (GSK) Biologicals.
The trial was conducted in compliance with the International Conference on Harmonization Good Clinical Practices, the Declaration of Helsinki and regulatory requirements of Mali.
Severe AEs were defined according to International Conference on Harmonization Good Clinical Practice guidelines.
According to the International Conference on Harmonization Good Clinical Practice guidelines, all information recorded was anonymized.
Systematic assessments for adverse events in efficacy safety studies generally followed the International Conference of Harmonization Good Clinical Practice guidelines.
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This study was conducted in accordance with the International Conference on Harmonization-Good Clinical Practice.
The trial was conducted in accordance with current International Conference on Harmonization-Good Clinical Practice guidelines and the Declaration of Helsinki and its subsequent revisions.
The study was conducted in accordance with the International Conference on Harmonization-Good Clinical Practice (ICH-GCP) and applicable local regulations in China.
Great effort has been undertaken by the SNM and EANM towards the importance of understanding International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and ensuring that the imaging department staff is trained in GCP.
A total of 22 patients enrolled from one site were excluded from the efficacy analysis due to serious non-compliance with International Conference on Harmonization-Good Clinical Practices at the site.
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