Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase

The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase.

Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of 6 months (end of LAR/Core phase) and at the end of 12 months (extension phase)

The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.

Pulse rate was defined as percentage of patients with change in pulse rate >=10 bpm from pre-OGTT to 30 minutes post OGTT.

The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.

Percentage of patients with change in hematocrit >= 3% from pre-OGTT to 30 minutes post OGTT.

The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.

Absolute insulin levels at the end of M3, M6, M12

The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.

Absolute glucagon levels at the end of Months 3, 6 & 12

The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.

Absolute Glucagon-like peptide 1 (GLP-1) levels at the end of at the end of Months 3, 6 and 12 at different time points.

The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.

Absolute Gastric Inhibitory Polypeptide (GIP) levels at the end of Months 3, 6 and 12 at different time points.

The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase.

The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.

Absolute HRQoL SF-36 Scores at end of the Months 3, 6 and 12 from s.c. baseline. SF-36, a 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.

Absolute Dumping Severity Score (DSS) scores at end of M3, M6 & M8. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients were expected to use DSQ. No results available for M12 as last patient that answered the DSS was at M8. DSS = disease-specific patient (Pt.) reported outcome (PRO) questionnaire uses a 4-point Likert scale (0, absent; 1, mild; 2, relevant; 3, severe; 4) to ask Pt. to evaluate intensity of early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). The questionnaire also evaluates 65 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). Early & late dumping score calculated by adding the scores of the respective questions. Cumulative dumping score is obtained by adding early & late scores. DSS Range (min (absent) - max (severe)): Early dumping: 0-24; Late Dumping: 0-18; Cumulative: 0-42. Lower scores represent a better outcome.

The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.

Absolute Dumping Score Questionnaire (DSQ) scores at end of Months 3, 6 & 12 from s.c. baseline. DSQ = disease-specific PRO scale. The questionnaire uses a 5-point Likert scale (0, none; 1, mild; 2, moderate; 3, severe; 4, very severe) to ask Pt. to evaluate intensity of 10 early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). The questionnaire also evaluates 5 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). Early & late dumping score calculated by adding the scores of respective questions. A cumulative dumping score is obtained by adding early & late scores. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients used DSQ. DSQ Range: (min (None) - max (Very severe)): Early dumping: 0-40; Late Dumping: 0-20; Cumulative: 0-60. Lower scores represent a better outcome.

The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.

Treatment with pasireotide LAR (both early and late dumping scores), was assessed by patient global assessment. Patient Global Assessment served as an additional approach to symptom based measurement by DSQ. It incorporated a patient global assessment question: "Considering all the ways that your disease affects you, rate how you are feeling during the last 7 days compared with your situation before starting the study" .Patients Global Assessment was measured utilizing a 7 point scale (from 1=a lot worse to 7= a lot better).

The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.

A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes. 'n' = number of subjects with non-missing values

The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).

A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.

The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).

A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.

The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).

The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).

Summary of plasma PK parameter Cmax, p2 , 2nd injection and Ctrough, d28 associated with LAR injection (LAR Core phase)

The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).

Summary of pasireotide concentrations following monthly i.m. injections of pasireotide LAR by incident dose (LAR Pharmacokinetic set)

The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).

In the LAR treatment phase, monthly injections of pasireotide LAR 10, 20, 30 and 40 mg were given to participants and trough concentration at steady state (Ctrough,ss) were obtained but due to only 1 participant in the 40mg arm, standard deviation could not be calculated.

The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).