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Complete and submit the report Online : www.fda.gov/medwatch/report.htm Regular Mail or Fax : Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Product Photos Source: FDA

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Written informed consent for participation in this study was provided by the participants’ legal guardians/next of kin