Handling of Withdrawals. Subjects are free to withdraw from the study at any time upon request. Subject participation in the study may be stopped at any time at the discretion of the investigator or at the request of the sponsor. When a subject withdraws from the study, the reason(s) for withdrawal shall be recorded by the investigator on the relevant page of the eCRF. Whenever possible, any subject who withdraws from the study prematurely will undergo all EOS assessments. Any subject who fails to return for final assessments will be contacted by the site in an attempt to have them comply with the protocol. The status of subjects who fail to complete final assessments will be documented in the eCRF. All subjects who prematurely discontinue study treatment should be encouraged to remain in the study and maintain the same protocol schedule and assessments as described in Table 3-1. This will allow for continued subject follow-up for key outcome data.
Handling of Withdrawals. Subjects are free to withdraw from the study at any time upon request. Subject participation in the study may be stopped at any time at the discretion of the investigator or at the request of SIGA. When a subject withdraws from the study, the reason(s) for withdrawal will be recorded by the investigator in the electronic case report form (eCRF). Whenever possible, any subject who withdraws from the study prematurely will undergo all Day 9/early discontinuation assessments (Table 9-1). Any subject who fails to return for final assessments will be contacted by the study site personnel in an attempt to have them comply with the protocol. The status of subjects who fail to complete final assessments will be documented in the eCRF.
