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Seek medical advice if you experience: New or worsening vision problems Severe or progressive weakness Loss of coordination or balance Confusion or cognitive changes Seizures These symptoms could indicate underlying conditions requiring investigation

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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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