Trial Outcomes & Findings for An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome (NCT NCT00774930)

NCT ID: NCT00774930

Last Updated: 2022-10-14

Results Overview

Use of s.c. octreotide required to control symptoms associated with carcinoid syndrome, measured as the percentage of days that s.c. octreotide was used as rescue medication, based on subject Interactive Voice Response System (IVRS) or Interactive Web Response System (IWRS) diary records.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 115 participants
• Primary outcome timeframe: 16-week DB phase
• Results posted on: 2022-10-14

Participant Flow

Subjects were recruited from multiple sites across countries from May 2009. The study was completed in December 2015.

A total of 153 subjects were screened; 115 were randomized and 38 failed screening.

Participant milestones

Measure	Lanreotide Autogel (Somatuline Depot) 120 mg Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the initial open label (IOL) phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the long term open label extension (LTOLE) phase.	Placebo Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
DB Phase STARTED	59	56
DB Phase COMPLETED	45	34
DB Phase NOT COMPLETED	14	22
IOL Phase STARTED	56	46
IOL Phase COMPLETED	43	37
IOL Phase NOT COMPLETED	13	9
LTOLE Phase STARTED	32	25
LTOLE Phase COMPLETED	17	8
LTOLE Phase NOT COMPLETED	15	17

Reasons for withdrawal

Measure	Lanreotide Autogel (Somatuline Depot) 120 mg Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the initial open label (IOL) phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the long term open label extension (LTOLE) phase.	Placebo Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
DB Phase Early Roll Over (ERO) to IOL phase	11	12
DB Phase Adverse Event	1	2
DB Phase Subject Decision	1	5
DB Phase Sponsor Decision	0	1
DB Phase Disease Progression	1	1
DB Phase Started Nonprotocol Radiation therapy	0	1
IOL Phase Adverse Event	1	1
IOL Phase Subject Decision	4	3
IOL Phase Physician Decision	3	2
IOL Phase Sponsor Decision	1	0
IOL Phase Disease Progression	2	1
IOL Phase Subject Consumed Prohibited Medication	1	0
IOL Phase Peptide Receptor Radionuclide Therapy	0	1
IOL Phase Other	1	0
IOL Phase Brain radiation	0	1
LTOLE Phase Adverse Event	7	3
LTOLE Phase Subject decision	0	5
LTOLE Phase Physician Decision	4	1
LTOLE Phase Sponsor decision	2	1
LTOLE Phase Disease Progression	2	5
LTOLE Phase Tumour Progression of Hepatic Metastases	0	1
LTOLE Phase Proton Pump Inhibitor Dose Adjusted	0	1

Baseline Characteristics

An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome

Baseline characteristics by cohort

Measure	Lanreotide Autogel (Somatuline Depot) 120 mg n=59 Participants Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase. Intent-to-treat (ITT) population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.	Placebo n=56 Participants Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.	Total n=115 Participants Total of all reporting groups
Age, Continuous	57.9 years STANDARD_DEVIATION 10.6 • n=5 Participants	59.3 years STANDARD_DEVIATION 11.6 • n=7 Participants	58.6 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	35 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	21 Participants n=7 Participants	48 Participants n=5 Participants
Race/Ethnicity, Customized Asian	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants
Race/Ethnicity, Customized Black/African American	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized White	44 participants n=5 Participants	44 participants n=7 Participants	88 participants n=5 Participants
Race/Ethnicity, Customized Multi race	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 16-week DB phase

Population: ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.

Use of s.c. octreotide required to control symptoms associated with carcinoid syndrome, measured as the percentage of days that s.c. octreotide was used as rescue medication, based on subject Interactive Voice Response System (IVRS) or Interactive Web Response System (IWRS) diary records.

Outcome measures

Measure	Lanreotide Autogel (Somatuline Depot) 120 mg n=59 Participants Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).	Placebo n=56 Participants Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Percentage of Days With Subcutaneous Octreotide as Rescue Medication	33.72 Percentage of days Interval 25.02 to 42.42	48.49 Percentage of days Interval 39.57 to 57.4

SECONDARY outcome

Timeframe: 16-week DB phase

Population: ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.

Outcome measures

Measure	Lanreotide Autogel (Somatuline Depot) 120 mg n=59 Participants Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).	Placebo n=56 Participants Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records.	1.56 Number of events per day Standard Deviation 1.83	1.35 Number of events per day Standard Deviation 1.45

SECONDARY outcome

Timeframe: 16-week DB phase

Population: ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.

Outcome measures

Measure	Lanreotide Autogel (Somatuline Depot) 120 mg n=59 Participants Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).	Placebo n=56 Participants Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records.	0.92 Number of events per day Standard Deviation 1.45	1.75 Number of events per day Standard Deviation 2.26

SECONDARY outcome

Timeframe: 16-week DB phase

Population: ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.

Usage of other concomitant rescue medications for diarrhoea and/or flushing events, measured as the percentage of days that the medications were used as rescue medication based on subject IVRS/IWRS diary records. Subjects were required to record the use and dose of s.c. octreotide, if any, as well as the use of other concomitant rescue medications (e.g. loperamide 2 mg tabs, and/or tincture of opium).

Outcome measures

Measure	Lanreotide Autogel (Somatuline Depot) 120 mg n=59 Participants Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).	Placebo n=56 Participants Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Percentage of Days of Use of Other Rescue Medication	8.86 Percentage of days Standard Deviation 19.34	6.25 Percentage of days Standard Deviation 17.48

SECONDARY outcome

Timeframe: 16-week DB phase

Population: ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.

Subjects who rolled over early were those who received less than four DB injections before receiving the first IOL injection.

Outcome measures

Measure	Lanreotide Autogel (Somatuline Depot) 120 mg n=59 Participants Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).	Placebo n=56 Participants Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study	18.6 Percentage of subjects	21.4 Percentage of subjects

SECONDARY outcome

Timeframe: Baseline and Week 12 of DB phase

Population: ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.

Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

Q29 and Q30 range from 1 (Very poor) to 7 (Excellent) with 1 being worst case and 7 the most favourable answer. Scores were derived according to the rules contained within the EORTC scoring manual. All of the scores range in score from 0 to 100. A high score for global health status/QoL represents high QoL. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. Raw score = RS = (I1 + I2 +…+ In)/n.

For global health status/QoL: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS.

Outcome measures

Measure	Lanreotide Autogel (Somatuline Depot) 120 mg n=48 Participants Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).	Placebo n=34 Participants Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Changes From Baseline in "Global Health Status/Quality of Life (QoL)" Score (Based on Items 29 and 30 of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-QLQ] C30)	4.17 Units on a scale Standard Deviation 14.18	-1.72 Units on a scale Standard Deviation 18.21

SECONDARY outcome

Timeframe: Baseline and Week 12 of DB phase

Population: ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.

Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +…+ In)/n.

For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS.

Outcome measures

Measure	Lanreotide Autogel (Somatuline Depot) 120 mg n=48 Participants Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).	Placebo n=33 Participants Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Changes From Baseline in "Gastrointestinal (G.I). Symptoms" Subscore (Based on Items Q34, Q35, Q36, Q37 and Q38 of EORTC G.I. Neuroendocrine Tumour [NET] 21]	-4.06 Units on a scale Standard Deviation 12.80	0.10 Units on a scale Standard Deviation 13.83

SECONDARY outcome

Timeframe: Baseline and Week 12 of DB phase

Population: ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.

Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +…+ In)/n.

For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS.

Outcome measures

Measure	Lanreotide Autogel (Somatuline Depot) 120 mg n=48 Participants Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).	Placebo n=33 Participants Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Changes From Baseline in QoL in "Endocrine Symptoms" Subscore (Assessed Based on Items Q31, Q32 and Q33 Using EORTC QLQ-G.I.NET-21 Questionnaires)	-6.83 Units on a scale Standard Deviation 18.98	-2.69 Units on a scale Standard Deviation 22.23

SECONDARY outcome

Timeframe: Baseline and Week 12 of DB phase

Population: ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.

Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

Outcome measures

Measure	Lanreotide Autogel (Somatuline Depot) 120 mg n=41 Participants Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).	Placebo n=28 Participants Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Absolute Changes From Baseline in Biochemical Markers (Plasma Chromogranin A [CgA])	1125.8 μg/L Standard Deviation 12579.4	801.5 μg/L Standard Deviation 2294.0

SECONDARY outcome

Timeframe: Baseline and Week 12 of DB phase

Population: ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.

Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

Outcome measures

Measure	Lanreotide Autogel (Somatuline Depot) 120 mg n=39 Participants Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).	Placebo n=27 Participants Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Absolute Changes From Baseline in Biochemical Markers (Urinary 5-hydroxyindoleacetic Acid [5-HIAA])	-201.4 μmol/day Standard Deviation 1009.9	36.3 μmol/day Standard Deviation 142.3

Adverse Events

Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase)

Serious events: 2 serious events

Other events: 31 other events

Deaths: 0 deaths

Placebo (DB Phase)

Serious events: 5 serious events

Other events: 34 other events

Deaths: 0 deaths

Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase)

Serious events: 8 serious events

Other events: 71 other events

Deaths: 0 deaths

Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase)

Serious events: 15 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase) n=58 participants at risk Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.	Placebo (DB Phase) n=57 participants at risk Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.	Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase) n=101 participants at risk All 101 subjects in the IOL phase received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks (56 and 45 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).	Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase) n=57 participants at risk All 57 subjects in the LTOLE phase received further deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (32 and 25 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).
Gastrointestinal disorders Small intestinal obstruction	1.7% 1/58 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	3.0% 3/101 • Number of events 4 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Infections and infestations Urinary tract infection	1.7% 1/58 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	1.7% 1/58 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Gastrointestinal disorders Vomiting	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Gastrointestinal disorders Abdominal pain	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Gastrointestinal disorders Diarrhoea	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Infections and infestations Kidney infection	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Nervous system disorders Cerebral ischaemia	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Nervous system disorders Hydrocephalus	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Ear and labyrinth disorders Deafness permanent	1.7% 1/58 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Infections and infestations Lower respiratory tract infection	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Infections and infestations Urosepsis	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to pleura	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Psychiatric disorders Mental status changes	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Renal and urinary disorders Ureteric stenosis	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Cardiac disorders Pericardial effusion	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
General disorders Disease progression	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Infections and infestations Sepsis	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	3.5% 2/57 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Infections and infestations Pyelonephritis	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Infections and infestations Pyelonephritis acute	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Infections and infestations Infection	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	3.5% 2/57 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Gastrointestinal disorders Subileus	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
General disorders Death	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
General disorders General physical health deterioration	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
General disorders Pyrexia	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Nervous system disorders Dizziness	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Nervous system disorders Sciatica	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Nervous system disorders Syncope	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.

Other adverse events

Measure	Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase) n=58 participants at risk Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.	Placebo (DB Phase) n=57 participants at risk Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.	Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase) n=101 participants at risk All 101 subjects in the IOL phase received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks (56 and 45 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).	Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase) n=57 participants at risk All 57 subjects in the LTOLE phase received further deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (32 and 25 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).
Gastrointestinal disorders Nausea	8.6% 5/58 • Number of events 5 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	8.8% 5/57 • Number of events 5 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	7.9% 8/101 • Number of events 9 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	7.0% 4/57 • Number of events 5 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Gastrointestinal disorders Vomiting	6.9% 4/58 • Number of events 6 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	3.5% 2/57 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.9% 6/101 • Number of events 6 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	8.8% 5/57 • Number of events 8 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Gastrointestinal disorders Abdominal pain	8.6% 5/58 • Number of events 5 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	12.3% 7/57 • Number of events 7 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	10.9% 11/101 • Number of events 14 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	22.8% 13/57 • Number of events 25 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Gastrointestinal disorders Abdominal pain upper	1.7% 1/58 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	4.0% 4/101 • Number of events 4 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	12.3% 7/57 • Number of events 9 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Nervous system disorders Headache	12.1% 7/58 • Number of events 7 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.3% 3/57 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	9.9% 10/101 • Number of events 15 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	8.8% 5/57 • Number of events 7 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Nervous system disorders Dizziness	6.9% 4/58 • Number of events 4 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.0% 5/101 • Number of events 5 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	3.5% 2/57 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
General disorders Fatigue	3.4% 2/58 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	7.0% 4/57 • Number of events 4 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	9.9% 10/101 • Number of events 10 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	15.8% 9/57 • Number of events 14 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
General disorders Oedema peripheral	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.3% 3/57 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	3.0% 3/101 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.3% 3/57 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
General disorders Pyrexia	1.7% 1/58 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	8.8% 5/57 • Number of events 6 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Infections and infestations Nasopharyngitis	3.4% 2/58 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	3.5% 2/57 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	12.3% 7/57 • Number of events 7 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Infections and infestations Upper respiratory tract infection	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	3.5% 2/57 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	3.0% 3/101 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.3% 3/57 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Musculoskeletal and connective tissue disorders Muscle spasms	5.2% 3/58 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.9% 6/101 • Number of events 6 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Musculoskeletal and connective tissue disorders Back pain	1.7% 1/58 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	7.0% 4/57 • Number of events 4 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.0% 5/101 • Number of events 5 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	14.0% 8/57 • Number of events 10 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	6.9% 7/101 • Number of events 8 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	10.5% 6/57 • Number of events 9 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	7.0% 4/57 • Number of events 4 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	3.0% 3/101 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	7.0% 4/57 • Number of events 4 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Metabolism and nutrition disorders Hypoglycaemia	3.4% 2/58 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.3% 3/57 • Number of events 7 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Metabolism and nutrition disorders Decreased appetite	1.7% 1/58 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	6.9% 7/101 • Number of events 8 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	8.8% 5/57 • Number of events 5 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Metabolism and nutrition disorders Hypertriglyceridaemia	1.7% 1/58 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	2.0% 2/101 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.3% 3/57 • Number of events 4 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Metabolism and nutrition disorders Gout	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.3% 3/57 • Number of events 4 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	4.0% 4/101 • Number of events 9 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	12.3% 7/57 • Number of events 12 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Investigations Weight decreased	1.7% 1/58 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	8.9% 9/101 • Number of events 9 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Investigations Blood creatine phosphokinase increased	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	2.0% 2/101 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.3% 3/57 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Psychiatric disorders Anxiety	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	3.0% 3/101 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.3% 3/57 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Respiratory, thoracic and mediastinal disorders Cough	3.4% 2/58 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	3.0% 3/101 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.3% 3/57 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	7.0% 4/57 • Number of events 4 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.9% 6/101 • Number of events 6 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	3.5% 2/57 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Hepatobiliary disorders Cholelithiasis	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.0% 5/101 • Number of events 5 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	7.0% 4/57 • Number of events 5 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Vascular disorders Hypertension	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	8.9% 9/101 • Number of events 10 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	8.8% 5/57 • Number of events 5 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Gastrointestinal disorders Constipation	3.4% 2/58 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	3.5% 2/57 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	4.0% 4/101 • Number of events 5 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	8.8% 5/57 • Number of events 5 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Gastrointestinal disorders Diarrhoea	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	14.0% 8/57 • Number of events 10 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
General disorders Influenza like illness	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.3% 3/57 • Number of events 4 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
General disorders Disease progression	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/101 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	8.8% 5/57 • Number of events 5 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.3% 3/57 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Investigations Blood triglycerides increased	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	2.0% 2/101 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	7.0% 4/57 • Number of events 5 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Investigations Gamma-glutamyltransferase increased	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	2.0% 2/101 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	8.8% 5/57 • Number of events 12 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Investigations Aspartate aminotransferase increased	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.3% 3/57 • Number of events 4 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Vascular disorders Flushing	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.3% 3/57 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Vascular disorders Hot flush	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.99% 1/101 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	5.3% 3/57 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Gastrointestinal disorders Flatulence	5.2% 3/58 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	3.0% 3/101 • Number of events 3 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
General disorders Asthenia	3.4% 2/58 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	1.8% 1/57 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	2.0% 2/101 • Number of events 2 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	10.5% 6/57 • Number of events 9 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.
Blood and lymphatic system disorders Anaemia	0.00% 0/58 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	0.00% 0/57 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	4.0% 4/101 • Number of events 4 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.	10.5% 6/57 • Number of events 7 • Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]). Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo. Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.

Additional Information

Medical Director, Oncology

Ipsen

Phone: clinical.trials@ipsen.com

Email: clinical.trials@ipsen.com

Results disclosure agreements

• Principal investigator is a sponsor employee With permission from the Sponsor, each investigator may have published or reported data from their own subjects. The study data in aggregate are the property of the Sponsor and may not be published without permission of the Sponsor. The Sponsor is the final arbitrator of issues relating to the publication or presentation of the aggregate data.
• Publication restrictions are in place

Restriction type: OTHER