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Cell Transplant 25(5):849861 Matsuyama N, Shimizu S, Ueda K, Suzuki T, Suzuki S, Miura R, Katayama A, Ando M et al (2022) Safety and tolerability of a multilineage-differentiating stress-enduring cell-based product in neonatal hypoxic-ischaemic encephalopathy with therapeutic hypothermia (SHIELD trial): a clinical trial protocol open-label, non-randomised, dose-escalation trial
Sixth, while the FAERS database provides valuable insights, exclusion of international pharmacovigilance databases such as the EudraVigilance or WHO VigiBase limits global generalizability, though accessibility constraints justify this approach