Premature Discontinuation from the Study Treatment Sample Clauses

Premature Discontinuation from the Study Treatment. A subject is deemed to have completed this study if they have completed the entire 156-week treatment period including Visit 16 (the follow-up visit). However, subjects who have prematurely withdrawn from study treatment will be followed up for 156 weeks from the start of treatment. During this period all study drug-related SAEs and all deaths must be reported as per Section 7 of the protocol. Premature discontinuation from the study treatment is when a subject discontinues either voluntarily or is withdrawn by the investigator for reasons such as: an adverse event; if it would be detrimental for the subject to continue; social reasons; lack of efficacy. All subjects who discontinue the study during the treatment period, must have a Follow-up visit two weeks after the withdrawal. In all cases the reason for premature discontinuation must be recorded in the End of Study Record section of the CRF. An adverse event form should be completed if necessary. A subject may voluntarily discontinue participation in this study at any time. The investigator may also, at his or her discretion, discontinue the subject from participating in this study at any time. If the subject has received study drug and is prematurely discontinued from participation in the study for any reason, the investigator must make every effort to perform the following evaluations: collect used/unused study medication and record compliance; check for adverse events, changes in concurrent medication, moderate and severe exacerbations since last visit, perform clinic lung function measurements (FEV1). These data should be recorded at a Follow-up visit, as they comprise an essential evaluation which should be done prior to discharging any subject from the study. In the event that a subject is prematurely discontinued from the study at any time due to an AE (as defined in Section 7.1, Definition of an AE) or SAE (as defined in Section 7.2, Definition of an SAE), the procedures stated in Section 7, (AEs and SAEs) must be followed.
Sample 1
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Related to Premature Discontinuation from the Study Treatment

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