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Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial HEALTHY SUBJECT: Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the study Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed 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informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Subjects between and years of age, inclusive, at the time of consent/assent, and able to provide written consent/assent, if applicable. Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Willing to provide informed consent/assent for study participation Willing to provide informed consent/assent for study participation Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial Be willing and able to provide written informed consent/assent for the trial