End of Study Sample Clauses

End of Study. Visit (7 ± 2 days after last study visit or decision to terminate) 54
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End of Study. ‌ End of Study will occur when the last patient has completed the 30-day Safety follow up period (after their last dose of study treatment), has withdrawn consent or has died, whichever comes first.
End of Study. Primary Completion: The primary completion of study will occur when target enrollment or randomization is complete and each participant does at least one of the following: • Has had the opportunity to complete the week 12 visit on study, or • Withdraws from study End of Trial: The end of trial will occur when target enrollment or randomization is complete and each participant either withdraws from study or completes the week 12 follow up visit or the week 24 long-term follow-up.
End of Study. Visit (7 ± 2 days after last study visit or decision to terminate) For all patients: • Collect and review completed diary. • Perform physical examination (see Section 9.10). • Measure height and weight. • Calculate BMI and BSA (see Appendix 14.5). • Measure xxxxx xxxxx (blood pressure, heart rate, respiratory rate, and oral body temperature, see Section 9.11). • Obtain clinical laboratory tests (serum chemistry, hematology, and urinalysis, see Section 9.7). • Obtain a 12-lead ECG (see Section 9.9). • • Administer the VAS measurement of swallowing difficulty (see Section 9.13). • Record concomitant medications. • Monitor AEs. For patients still receiving RP103 treatment: • Subjects should be fasting for at least 2 hours prior to RP103 dosing. • A meal or snack will be ingested between 30 and 60 minutes after RP103 dosing. • Administer Q12H RP103 dose with an acceptable food or liquid as described in Appendix 14.9. • Collect a cysteamine PK sample 0.5 hour (30 minutes) post RP103 dose administration. Actual collection time will be recorded. • Collect a WBC cystine PD sample 0.5 hour (30 minutes) post RP103 dose administration. Actual collection time will be recorded. For patients that terminated from the Study and transitioned onto Cystagon® treatment: • Collect a cysteamine PK sample immediately prior to their next Cystagon® dose administration. Actual collection time will be recorded. • Collect a WBC cystine PD sample immediately prior to their next Cystagon® dose administration. Actual collection time will be recorded. If a subject has any clinically significant, Study drug-related abnormalities at the conclusion of the study termination, the Investigator will determine if the subject has to be followed further. If the Investigator determines that a subject has abnormalities that require additional monitoring, the subject may be asked to return to the clinic until the abnormalities resolve or will be allowed to return home and will be followed up by telephone until resolution. If the subject is to be followed up, the Medical Monitor (or designated representative) should be notified. Every effort should be made to arrange follow-up evaluations at appropriate intervals to document the course of the abnormalities.

Related to End of Study

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