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Immunohistochemical observations were consistent with the ultrastructural findings. In Group II, high apoptosis and unstained/irregular TJ formation in claudin-11, occludin and ZO-1 were observed. In conclusion, disruption of relation between BTB and TJs may reveal inadequate spermatogenesis, which is one of the mechanisms behind azoospermia.The development of modified-release (MR) drug products aims to address a clinical need such as improving patient compliance. There are multiple pathways and development strategies for the registration and