Discontinued Subjects. Discontinued subjects are those who withdraw or are withdrawn from the study after signing the informed consent, including screen failures. Subjects may discontinue from the study at any time for any reason. Subjects may also be discontinued from the study at any time if, in the opinion of the Investigator, their continued participation poses a risk to their health. Discontinued subjects will not be replaced (ie, their subject numbers will not be re-assigned/re-used). Should a subject exhibit any clinically relevant signs, symptoms, or other clinical observations that possibly could be associated with suspected sensitivity or intolerance to one of the study treatments, the Investigator must document those observations on an AE Form. Any subject who exits early from the study (excluding screen failures) must undergo all procedures outlined at Visit 3, as applicable. The Investigator must document the reason for study or treatment discontinuation in the subject’s case history source documents. To ensure the safety of all subjects who discontinue early, Investigators must assess each subject and, if necessary, advise them of any therapies and/or medical procedures that may be needed to maintain their health.
Discontinued Subjects. Any subject is free to discontinue his/her participation in this study at any time and for whatever reason, specified or unspecified, and without prejudice. An Investigator may decide to discontinue a subject from the study for safety reasons or when it is in the best interest of the subject. Galderma Laboratories, L.P. may also decide to prematurely terminate or suspend the study or the participation of a subject in the study. All data gathered on the subject prior to termination should be made available to Galderma Laboratories, L.P. Criteria for the discontinuation of a subject during the study will include the following: • Adverse Event • Lack of Effect • Pregnancy • Subject Request • Protocol Violation • Lost to Follow-up • Any unmanageable factor, in the Investigator’s opinion, that may significantly interfere with the protocol or interpretation of results.
Discontinued Subjects. Discontinued subjects are those who withdraw or are withdrawn from the study after signing the informed consent, including screen failures. Subjects may discontinue from the study at any time for any reason. Subjects may also be discontinued from the study at any time if, in the opinion of the investigator, their continued participation poses a risk to their health. Discontinued subjects will not be replaced (i.e., their subject numbers will not be reassigned/reused). Should a subject exhibit any clinically relevant signs, symptoms, or other clinical observations that possibly could be associated with suspected sensitivity or intolerance to one of the study treatments, the investigator must document those observations on an AE Form. Any subject who exits early from the study (excluding screen failures) must undergo all Exit procedures according to Table 1-1: Schedule of Study Procedures and Assessments. The investigator must document the reason for study or treatment discontinuation in the subject’s case history source documents. To ensure the safety of all subjects who discontinue early, investigators must assess each subject and, if necessary, advise them of any therapies and/or medical procedures that may be needed to maintain their health.
Discontinued Subjects. Discontinued subjects withdraw, or are withdrawn from the study after signing consent, and prior to completing all study visits. Subjects signing consent, but withdrawing or withdrawn prior to randomization shall be considered discontinued due to screen failure, and the failed entry criterion documented (eg, inclusion criterion 2, exclusion criterion 5). Refer to Section 10
Discontinued Subjects. If a Subject discontinues participation in a Study, or this Addendum is terminated, only those costs incurred up until the date of discontinuation or termination will be paid, according to the above- referenced Per Subject payment schedule, provided that all CRFs have been completed by Institution and subsequently reviewed by AstraZeneca. If a Subject discontinues between visits and does not complete each of the Study visits, Institution will be paid only for visits that the Subject completes. Partial visits will not be paid. Payment will be made on a [bi-weekly, monthly, bi-monthly, quarterly] basis throughout the term of a Study, beginning in approximately .
Discontinued Subjects. If a Subject discontinues participation in the Study, or this Project Agreement is terminated, only those costs incurred up until the date of discontinuation or termination will be paid, according to the above- referenced per Subject payment schedule, provided that all CRFs have been completed by Institution and subsequently reviewed by the Company. If a Subject discontinues between visits and does not complete each of the Study visits, Institution will be paid only for visits that the Subject completes. If a Subject fails to complete all required procedures in a visit, Institution may invoice for procedures actually completed.
Discontinued Subjects
