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After one-third of the study participants have been enrolled and completed follow-up, the DSMBs will review the data and make recommendations concerning continuation, modification or termination of the study due to unexpectedly large beneficial effects or serious side effects and can suggest extension of the trial should the primary outcomes occur less often than anticipated

Usually, we see improvements in a few weeks

As confirmation, we used the crisis that occurred with the high intra-abdominal pressure-induced syndrome, in which intra-abdominal hypertension simultaneously affected all abdominal vessels and organs for a considerable period and restrained the ability to recruit alternative pathways, such that a deadly situation was created before therapy initiation

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