What this trial measures

• Number of Adverse Eventsthrough study completion, an average of 10 years

  Safety will be assessed by the number of Adverse events.These will be recorded via physical examination findings and will be presented in data listings. Clinically significant changes on physical exam in the areas of: general appearance, head, ears, eyes, nose, throat, neck, chest and lungs, cardiovascular, abdomen, neurological, thyroid, musculoskeletal, lymph nodes, extremities and skin, and operative site will be recorded as Adverse Events.

• Safety: Vital signs: Systolic Blood Pressurethrough study completion, an average of 10 years

  Systolic Blood Pressure: Criteria for Clinically Relevant Vital Signs Abnormalities: \>180 mmHg or an increase from pre-dosing of more than 40 mmHg, or \<90 mmHg or a decrease from pre-dosing of more than 30 mmHg

• Safety Endpoints: Vital signs: Diastolic Blood Pressurethrough study completion, an average of 10 years

  Diastolic Blood Pressure: Criteria for Clinically Relevant Vital Signs Abnormalities: \>105 mmHg or an increase from pre-dosing of more than 30 mmHg, or \<50 mmHg or a decrease from pre-dosing of more than 20 mmHg

• Safety Endpoints: Vital signs: Pulsethrough study completion, an average of 10 years

  Pulse: Criteria for Clinically Relevant Vital Signs Abnormalities: \>120 beats per minute or an increase from pre dosing of more than 20 beats per minute, or \<50 beats per minute or a decrease from pre dosing of more than 20 beats per minute

• Safety Endpoints: Vital signs: Temperaturethrough study completion, an average of 10 years

  Temperature: Criteria for Clinically Relevant Vital Signs Abnormalities: \>38.5°C and an increase from pre-dosing of at least 1°C

• Safety as measured by change in Electrocardiogram (ECG) measures from baseline at 10 yearsthrough study completion, an average of 10 years (Baseline, 10 years)

  Number of participants with abnormal ECG readings will be summarized using descriptive statistics by original treatment cohort and visit. ECG findings that are determined to be potentially clinically significant will be summarized.

• Safety Endpoints: Clinical Laboratory assessments: chemistrythrough study completion, an average of 10 years

  Descriptive statistics for raw values as well as change from baseline (entry into this protocol No. QLTFU-101) by original treatment group will be presented for each visit. The number and percentage of subjects with potentially clinically significant laboratory results will be tabulated by original treatment cohort and overall.

• Safety Endpoints: Clinical Laboratory assessments: hematologythrough study completion, an average of 10 years

  Descriptive statistics for raw values as well as change from baseline (entry into this protocol No. QLTFU-101) by original treatment group will be presented for each visit. The number and percentage of subjects with potentially clinically significant laboratory results will be tabulated by original treatment cohort and overall.