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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

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The ionic strength in the titrated and thermostat controlled (at 25°C) samples of 6.00 ml was kept constant and set to 0.15 M NaCl