Withdrawal Criteria. Patients may withdraw from the study at any time and for any reason. Reasons for discontinuation include, but are not limited to, the following: • Physician decision • Adverse Event any AEs continuing at the time of withdrawal should be followed until resolution or determined by the Investigator to be chronic or stable • Pregnancy • Withdrawal by subject • Study terminated by sponsor • Protocol violation • Disallowed concomitant medication. Patient’s use of, or need for, concomitant therapy liable to interfere with the interpretation of study endpoints. The Investigator will report all such information on the electronic Case Report Form (eCRF) and decide, in accordance with the Medical Monitor, whether the patient should be withdrawn from the study. • Lost to follow-up. The Investigator will try to reach the patient, at least twice by telephone and once by certified letter, before considering the patient lost-to-follow- up. These actions will be reported on the appropriate source documents, and a copy of the certified letter will be maintained in the Investigator’s file. All premature discontinuations and their causes must be documented by the Investigator on the appropriate eCRF page, and if need be, on the Adverse Event page of the eCRF. Patients not completing the entire study should be fully evaluated (i.e., final visit procedures performed), wherever possible. All patients are free to withdraw from participating in this study at any time and for whatever reason, specified or unspecified, and without prejudice to their medical care. Subjects may withdraw consent and/or may be discontinued by the investigator or Sponsor for any reason at any time.
Withdrawal Criteria. Because of the pragmatic design, this study will not have withdrawal criteria. However, over the course of the study, a participant may develop an exclusion criterion (e.g., become pregnant); in this case, the participant may be withdrawn from the study by the Recruitment and Retention Workgroup.
Withdrawal Criteria. The following circumstances shall result in a subject’s discontinuation from the study: • the subject undergoes repeat treatment other than Touch-up at Day 14 or study retreatment • If subject is administered any of the prohibited procedures listed as exclusionary in Section 4.3 • Subject is lost to follow-up. Subjects may be withdrawn if they do not return for follow-up visits. If a subject fails to return for one or more scheduled study visits, the Investigator will attempt to contact the subject to determine and document the reason the subject has failed to return and to encourage compliance with the study visit schedule. The following circumstances may result in a subject’s discontinuation from the study: • AEs or serious adverse events (SAEs) that render the subject unable to continue study participation • Protocol violation • Non-compliance with study requirements • Discretion of Investigator (must document reason on eCRF) • Progressive injury (at the discretion of the Investigator) • There are changes in the subject’s condition that render the subject unacceptable for further participation in the judgment of the Investigator • A subject is unable to physically or mentally tolerate the use of the test treatment 9 ADVERSE EVENTS Throughout the course of the study (from the date of informed consent), all AEs will be monitored and recorded in source documents and on the AE eCRF. If an AE occurs, the first concern will be the safety of the study participant. All AEs related to study treatments or procedures will be followed until resolved or stabilized based on the Investigator’s clinical judgement.
