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Before accepting the unit into stores, check three things: The outer carton seal is intact The pen cap is unbroken The printed lot number on the pen matches the certificate of analysis supplied with the consignment Any mismatch is grounds to quarantine the unit and contact us directly

So do we think that these are going to be waived off as rare occurrences that happen, maybe based on other factors, or that they would be actually taken seriously

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All the participants provided written informed consent to participate in this study