Table 2.

Subject withdrawal criteria

Subject withdrawal criteria
1. Protocol violation: detection of eligibility violations, poor compliance (mean compliance < 70% at the last estimation) or noncompliance, use of any forbidden medication or treatment during the trial that could affect the study results, occurrence of other significant protocol violation during the trial
2. Occurrence of a serious adverse event
3. Subject has an acute reaction (allergy, shock and so on) to the investigational product
4. Detection of a systemic disease that was not discovered at the screening stage
5. Unable to progress because of worsening of preexisting disease
6. Subject's withdrawal of consent
7. Subject is uncooperative
8. Investigator's decision to terminate the process for the sake of the subject's health