WITHDRAWAL CRITERIA AND PROCEDURES. All subjects have the right to withdraw at any point during the study without prejudice. The investigator can discontinue any subject, at any time, if medically necessary. The reason for subject’s withdrawal should be documented on the appropriate study-specific data form. The subject must undergo the recommended follow-up assessments specified for the last study visit unless contraindicated due to a medical condition. Withdrawn subjects will not be replaced.
WITHDRAWAL CRITERIA AND PROCEDURES. In accordance with the Declaration of Helsinki (in accordance with the applicable country’s acceptance), each patient is free to withdraw from the study at any time. Each investigator also has the right to withdraw a patient from the study in the event of intercurrent illness, adverse events, pregnancy (see section 7.2.4), or other reasons concerning the health or well-being of the patient, or in the case of lack of cooperation. In addition, a patient may be withdrawn from the study as described in sections 3.6, 3.8, 5.2, 5.3, and 7.1.6. Should a patient decide to withdraw after administration of study drug, or should the investigator decide to withdraw the patient, all efforts will be made to complete and report the observations up to the time of withdrawal as thoroughly as possible. A complete final evaluation at the time of the patient’s withdrawal should be made and an explanation given of why the patient is withdrawing or being withdrawn from the study. The reason for and date of withdrawal from study drug treatment and the reason for and date of withdrawal from the study must be recorded on the CRF. If a patient withdraws consent, every attempt will be made to determine the reason. If the reason for withdrawal is an adverse event or a clinically significant abnormal laboratory test result, monitoring will continue until the event has resolved or stabilized, until the patient is referred to the care of a local health care professional, or until a determination of a cause unrelated to the study drug or study procedure is made. The specific event or test results must be recorded on the CRF. In addition, a blood sample will be obtained for measurement of the concentration of IPP-201101 from all patients who have a serious adverse event and/or have an adverse event leading to withdrawal from the study. All evaluations should be performed, according to the protocol, on the last day the patient receives study drug, or as soon as possible thereafter.
